Clinical Trials /

Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer

NCT03775265

Description:

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

Related Conditions:
  • Bladder Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
  • Official Title: Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806)

Clinical Trial IDs

  • ORG STUDY ID: NCI-2018-03264
  • SECONDARY ID: NCI-2018-03264
  • SECONDARY ID: S1806
  • SECONDARY ID: S1806
  • SECONDARY ID: U10CA180888
  • NCT ID: NCT03775265

Conditions

  • Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall
  • Bladder Urothelial Carcinoma
  • Stage II Bladder Cancer AJCC v8
  • Stage III Bladder Cancer AJCC v8
  • Stage IIIA Bladder Cancer AJCC v8

Interventions

DrugSynonymsArms
AtezolizumabMPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, TecentriqArm II (RT, chemotherapy, atezolizumab)
CisplatinAbiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone''s Chloride, Peyrone''s Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, PlatosinArm I (RT, chemotherapy)
Fluorouracil5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757Arm I (RT, chemotherapy)
GemcitabinedFdC, dFdCyd, DifluorodeoxycytidineArm I (RT, chemotherapy)
MitomycinAmetycine, MITO, MITO-C, Mito-Medac, Mitocin, Mitocin-C, Mitolem, Mitomycin C, Mitomycin-C, Mitomycin-X, Mitomycine C, Mitosol, Mitozytrex, Mutamycin, Mutamycine, NCI-C04706Arm I (RT, chemotherapy)

Purpose

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To compare bladder intact event-free survival (BI-EFS) for concurrent chemoradiation
      therapy (CRT) with and without atezolizumab in localized muscle invasive bladder cancer
      (MIBC).

      SECONDARY OBJECTIVES:

      I. To compare overall survival between the two arms. II. To compare modified bladder intact
      event-free survival including cancer related death between arms.

      III. To compare complete and partial pathologic response between arms at 3 months after
      completing chemoradiation therapy.

      IV. To estimate metastases-free survival by arm. V. To compare the qualitative and
      quantitative adverse events from each arm. VI. To estimate the rate of non-muscle invasive
      bladder cancer recurrence by arm.

      VII. To estimate the rate of salvage cystectomy and reasons for cystectomy by arm.

      VIII. To compare mean patient-reported global quality of life (QOL) at week 54 using the
      European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire
      (QLQ)-Core (C)30 Global Health Status (GHS) subscale score between patients with localized
      muscle-invasive bladder cancer randomized to chemoradiation with versus (vs.) without
      atezolizumab.

      TRANSLATIONAL MEDICINE OBJECTIVES:

      I. To test the hypothesis that a panel of validated biomarkers of concurrent CRT involving
      nuclear MRE11, impaired deoxyribonucleic acid damage response (DDR) function and tumor
      subtyping will be prognostic for BI-EFS among patients receiving either concurrent CRT or
      chemoimmuno-radiotherapy (CIRT) of the primary tumor.

      II. To test the hypothesis that tumor total mutation burden, neoantigen burden, infiltrating
      immune response, PD-L1 expression and T cell response are associated with augmented response
      after concurrent CIRT.

      III. To bank urine specimens for future use.

      PATIENT-REPORTED OUTCOMES (PROs) OBJECTIVES:

      I. To compare mean patient-reported global QOL as measured by the EORTC QLQ-C30 Global Health
      Status subscale scores at week 54 between patients with localized muscle-invasive bladder
      cancer randomized to chemoradiation with versus without atezolizumab.

      II. To compare mean patient-reported bowel symptoms at each assessment time by arm using the
      Bowel Domain of the Expanded Prostate Index (EPIC- 26) short form, the bladder-specific
      supplement to the QLQ-C30, the EORTC QLQ-Muscle Invasive Bladder Cancer (BLM30), the Physical
      Functioning subscale of the EORTC QLQ-C30, and overall health status using the EuroQol Five
      Dimension Five Level Scale (EQ-5D-5L).

      III. To compare longitudinal change over time by arm in patient-reported global QOL using the
      EORTC QLQ-C30, the Bowel Domain of the Expanded Prostate Index (EPIC-26) short form, the
      bladder-specific supplement to the QLQ-C30, the EORTC QLQ-BLM30, the Physical Functioning
      subscale of the EORTC QLQ-C30, and overall health status using the EQ-5D-5L.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients undergo radiation therapy (RT) (3 dimensional [D] CRT or intensity-modulated
      radiation therapy [IMRT]) Monday-Friday for up to 7 weeks. Patients also receive chemotherapy
      based on physician's choice of gemcitabine intravenously (IV) twice weekly for 6 weeks, or
      cisplatin IV weekly for 6 weeks concurrent with RT, or fluorouracil IV on same days as doses
      1-5 and 16-20 of radiation therapy, and mitomycin IV on day 1 of radiation therapy in the
      absence of disease progression or unacceptable toxicity.

      ARM II: Patients undergo RT (3DCRT or IMRT) Monday-Friday for up to 7 weeks and receive
      chemotherapy based on physician's choice as in Arm I. Patients also receive atezolizumab IV
      over 60 minutes on day 1 of chemotherapy. Treatment repeats every 21 days for a total of 6
      months (9 doses total) in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 2 years,
      then every 6 months for 1 year, and then annually for 3 years.
    

Trial Arms

NameTypeDescriptionInterventions
Arm I (RT, chemotherapy)Active ComparatorPatients undergo RT (3D CRT or IMRT) Monday-Friday for up to 7 weeks. Patients also receive chemotherapy based on physician's choice of gemcitabine IV twice weekly for 6 weeks, or cisplatin IV weekly for 6 weeks concurrent with RT, or fluorouracil IV on same days as doses 1-5 and 16-20 of radiation therapy, and mitomycin IV on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity.
  • Cisplatin
  • Fluorouracil
  • Gemcitabine
  • Mitomycin
Arm II (RT, chemotherapy, atezolizumab)ExperimentalPatients undergo RT (3DCRT or IMRT) Monday-Friday for up to 7 weeks and receive chemotherapy based on physician's choice as in Arm I. Patients also receive atezolizumab IV over 60 minutes on day 1 of chemotherapy. Treatment repeats every 21 days for a total of 6 months (9 doses total) in the absence of disease progression or unacceptable toxicity.
  • Atezolizumab
  • Cisplatin
  • Fluorouracil
  • Gemcitabine
  • Mitomycin

Eligibility Criteria

        Inclusion Criteria:

          -  STEP 1 REGISTRATION:

          -  If this will be the first patient from a registering site to receive a given RT
             modality (3DCRT vs. IMRT), the site must first submit pre-RT planning documents within
             3 days of Step 1 registration and receive approval from Imaging and Radiation Oncology
             Core (IROC) before randomizing the patient to Step 2. If this will not be the first
             patient to receive a specific RT modality, the patient should be immediately
             randomized to Step 2 on the same day.

          -  STEP 2 RANDOMIZATION

          -  If patient required review of pre-RT planning, randomization must occur within 14 days
             of initial registration.

          -  Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the
             bladder within 70 days prior to randomization. Patients with mixed urothelial
             carcinoma will be eligible for the trial, but the presence of small cell carcinoma
             will make a patient ineligible. Patients with lymph nodes >= 1.0 cm in shortest
             cross-sectional diameter on imaging (computed tomography [CT]/magnetic resonance
             imaging [MRI]) must have a biopsy of the enlarged lymph node showing no tumor
             involvement within 70 days prior to randomization. These patients may be suitable for
             neoadjuvant chemotherapy and radical cystectomy and are eligible for this trial if
             they seek out a bladder sparing treatment strategy, however patients who have received
             prior systemic chemotherapy for bladder cancer are not eligible for the trial.

          -  Patients must undergo a transurethral resection of bladder tumor (TURBT) within 70
             days prior to randomization. In a situation where a patient is referred from outside
             to the enrolling institution, patient must have a repeat cystoscopy by the urologist
             who will be following the patient on the clinical trial to assess the adequacy of the
             prior TURBT. Patient may then undergo repeat TURBT if deemed necessary as standard of
             care by the treating urologist. Patients may have either completely or partially
             resected tumors as long as the treating urologist attempted maximal resection. Patient
             must not have T4b disease.

          -  Patients must undergo radiological staging within 70 days prior to randomization.
             Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must
             not have evidence of T4bN1-3 disease. Eligibility is based on the local radiology
             report.

          -  Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and
             kidney function meets criteria specified.

          -  Patients must not have had urothelial carcinoma or histological variant at any site
             outside of the urinary bladder within the previous 24 months except Ta/T1/carcinoma in
             situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient
             had undergone complete nephroureterectomy.

          -  Patients must not have diffuse CIS based on cystoscopy and biopsy.

          -  Patient must be planning to receive one of the protocol specified chemotherapy
             regimens.

          -  All adverse events associated with any prior surgery and intravesical therapy must
             have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade =< 2
             prior to randomization.

          -  Patient must not have received any systemic chemotherapy for their bladder cancer.

          -  Patient must not have had prior pelvic radiation.

          -  Patients must not have received prior treatment for muscle invasive bladder cancer
             including neoadjuvant chemotherapy for the current tumor.

          -  Patients must not have received any systemic therapy (including, but not limited to,
             interferon alfa-2b, high dose IL-2, pegylated interferon [PEG-IFN], anti-PD-1,
             anti-PD-L1), for non-muscle invasive bladder cancer. Prior intravesical BCG,
             interferon, and intravesical chemotherapy are allowed.

          -  Patients must not have received any of the following prohibited therapies within 28
             days prior to randomization or be planning to receive any of the following prohibited
             therapies during protocol treatment:

               -  Anti-cancer systemic chemotherapy or biological therapy not specified in the
                  protocol.

               -  Immunotherapy not specified in this protocol.

               -  Systemic or intravesical use of any non-study anti-cancer agent (investigational
                  or non-investigational).

               -  Investigational agents other than atezolizumab.

               -  Live vaccines: Examples of live vaccines include, but are not limited to, the
                  following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies,
                  bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza
                  vaccines for injection are generally killed virus vaccines and are allowed;
                  however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated
                  vaccines, and are not allowed. Prior administration of intravesical BCG is
                  allowed.

               -  Glucocorticoids for any purpose other than to modulate symptoms from an event of
                  suspected immunologic etiology. The use of physiologic doses of corticosteroids
                  (defined as 10 mg prednisone) are acceptable, however site investigators should
                  consult with the study chair for any dose higher than 10 mg prednisone.
                  Dexamethasone 4 mg iv with chemotherapy to prevent nausea is allowed.

               -  RANKL infusion: Concurrent denosumab (which binds the cytokine RANKL) for any
                  known indication is prohibited due to interaction with study medication.

          -  Patients must not have a major surgical procedure within 28 days prior to
             randomization. If patient had any surgical procedure then they should have recovered
             to full presurgical performance status and surgical adverse events should have
             resolved to grade =< 2. TURBT is not considered a major surgical procedure.

          -  Patients must not have received treatment with systemic immunosuppressive medications
             (including, but not limited to, prednisone, cyclophosphamide, azathioprine,
             methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14
             days prior to randomization. Exceptions:

               -  Patients may have received acute, low dose, systemic immunosuppressant
                  medications (e.g., a one-time dose of dexamethasone for nausea).

               -  The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone)
                  for patients with orthostatic hypotension or adrenocortical insufficiency is
                  allowed. Physiological doses equivalent of 10 mg prednisone daily are allowed.
                  Short term steroids given as antiemetic therapy, e.g. 4 mg dexamethasone or
                  equivalent once a week, is allowed.

          -  Patients must not have received a live, attenuated vaccine within 4 weeks prior to
             randomization or anticipate that such a live, attenuated vaccine will be required
             while on protocol treatment and up to 5 months after the last dose of protocol
             treatment.

               -  Inactivated influenza vaccination should be given during influenza season only
                  (approximately October to March). Patients must not receive live, attenuated
                  influenza vaccine within 4 weeks prior to randomization or while on protocol
                  treatment and up to 5 months after the last dose of protocol treatment.

          -  Patients must not have undergone prior allogeneic bone marrow transplantation or prior
             solid organ transplantation.

          -  Patient may or may not be radical cystectomy candidates.

          -  Absolute neutrophil count (ANC) >=1,500/microliter (mcL) (within 28 days prior to
             randomization).

          -  Platelets >= 100,000/mcL (within 28 days prior to randomization).

          -  Hemoglobin >= 9 g/dL (within 28 days prior to randomization).

          -  Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except patients
             with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) (within 28 days
             prior to randomization).

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x IULN
             (within 28 days prior to randomization).

          -  Patients must not have clinically significant liver disease that precludes patient
             from treatment regimens prescribed on the study (including, but not limited to, active
             viral, alcoholic or other autoimmune hepatitis, cirrhosis or inherited liver disease).

          -  Patients must have adequate renal function as evidenced by calculated creatinine
             clearance >= 25 mL/min. The creatinine used to calculate the clearance result must
             have been obtained within 28 days prior to randomization.

          -  Patients must have Zubrod performance status =< 2.

          -  Patients must have a baseline electrocardiography (ECG) performed within 30 days prior
             to randomization.

          -  Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including
             drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic
             organizing pneumonia, etc.), or evidence of active pneumonitis.

          -  Patients must not have an active infection requiring oral or IV antibiotics within 14
             days prior to randomization. Patients receiving prophylactic antibiotics (e.g., for
             prevention of a urinary tract infection or chronic obstructive pulmonary disease) are
             not eligible. If patient develops urinary tract infection after TURBT they must have
             recovered from the infection prior to registration.

          -  Patients must not have active autoimmune disease that has required systemic treatment
             in past two years (i.e., with use of disease modifying agents, corticosteroids or
             immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or
             physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency,
             etc.) is not considered a form of systemic treatment. Autoimmune diseases include, but
             are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory
             bowel disease, vascular thrombosis associated with antiphospholipid syndrome,
             Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome,
             multiple sclerosis, autoimmune thyroid disease, vasculitis, Graves' disease treated
             with methimazole or glomerulonephritis.

          -  Patient must not have a history of active tuberculosis.

          -  If patient has a known history of hepatitis B virus (HBV) or hepatitis C virus (HCV),
             they must meet the following criteria within 28 days prior to randomization.

               -  Patients with past or resolved hepatitis B infection (defined as having a
                  negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc
                  [antibody to hepatitis B core antigen] antibody test) are eligible.

               -  Patients positive for hepatitis C virus (HCV) antibody are eligible only if
                  polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).

          -  Patients who are known to be positive for human immunodeficiency virus (HIV) are
             eligible only if they have all of the following:

               -  A stable regimen of highly active anti-retroviral therapy (HAART)

               -  No requirement for concurrent antibiotics or antifungal agents for the prevention
                  of opportunistic infections

               -  A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard
                  PCR-based tests within 28 days prior to randomization.

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             Stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease free for two years. Patients with
             localized prostate cancer who are being followed by an active surveillance program are
             also eligible.

          -  Female patients of childbearing potential must have a serum pregnancy test prior to
             randomization. Patients must not be pregnant or nursing due to the potential
             teratogenic side effects of the protocol treatment. Women of child-bearing potential
             and men must agree to use adequate contraception (hormonal or barrier method of birth
             control; abstinence) prior to study entry, for the duration of protocol treatment, and
             for 5 months (150 days) after the last dose of all study drugs. A woman is considered
             to be of "reproductive potential" if she has had a menses at any time in the preceding
             12 consecutive months.

          -  Patients must not be known to be allergic to Chinese hamster egg or ovary cell
             products and must not have any known major allergic reactions to any study drug.

          -  Patients must be offered the opportunity to participate in specimen banking for future
             studies.

          -  Patients who can complete Patient-Reported Outcome instruments in English or Spanish
             must agree to complete the EORTC QLQ-C30, the EORTC QLQ-BLM30, the EPIC-26 (bowel
             domain only), and the EQ-5D-5L per protocol schedule of assessment.

          -  As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
             treating institution's identity is provided in order to ensure that the current
             (within 365 days) date of institutional review board approval for this study has been
             entered in the system.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Bladder intact event-free survival (BI-EFS)
Time Frame:From the date of randomization to the first documentation of a BI-EFS event, assessed up to 5 years
Safety Issue:
Description:At each time point, futility will be evaluated, and in the latter two analyses, efficacy will also be evaluated as specified. The final BI-EFS intent-to-treat analysis will be conducted using a stratified logrank test stratifying on stratification factors, and testing treatment at the one-sided significance level of 0.022 to account for multiple interim testing. The hazard ratio (HR) will be estimated using a stratified Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median BI-EFS for each treatment arm.

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:From date of randomization to death from any cause, assessed up to 5 years
Safety Issue:
Description:Will be estimated using Kaplan-Meier methodology for each treatment arm. Will be analyzed using a similar method as for BI-EFS.
Measure:Modified BI-EFS (mBI-EFS)
Time Frame:From date of randomization to the first documentation of a mBI-EFS event, assessed within 90 days
Safety Issue:
Description:Analysis of modified BI-EFS, i.e., a sensitivity analysis of BI-EFS, where bladder cancer event is defined as histologically proven presence of muscle invasive bladder cancer, clinical evidence of nodal or metastatic disease, radical cystectomy, or death within 90 days of receiving protocol specified treatment, will also be conducted.
Measure:Biopsy response
Time Frame:At 18 weeks
Safety Issue:
Description:The Cochran-Mantel-Haenszel statistic will be used with modified ridit scores to evaluate the biopsy outcomes of complete response versus (vs.) down-staging vs. no response for the two treatment arms.
Measure:Complete response duration
Time Frame:At 18 weeks
Safety Issue:
Description:For the subset of patients who achieve a complete response during the week 18 biopsy window, complete response duration is defined from the date of the biopsy documenting the complete response to the time of muscle invasive recurrence, local progression, evidence of metastatic disease or death due to any cause. Will be analyzed using a similar method as for BI-EFS.
Measure:Progression-free survival
Time Frame:From date of randomization to first radiologic or histologic evidence of local progression, nodal or distant metastasis, or death due to any cause, assessed up to 5 years
Safety Issue:
Description:Will be estimated using Kaplan-Meier methodology for each treatment arm. Will be analyzed using a similar method as for BI-EFS.
Measure:Metastasis-free survival
Time Frame:From date of randomization to first radiologic or histologic evidence of metastatic disease or death due to any cause, assessed up to 5 years
Safety Issue:
Description:Will be estimated using Kaplan-Meier methodology for each treatment arm. Will be analyzed using a similar method as for BI-EFS.
Measure:Cancer-specific survival
Time Frame:From date of randomization to date of death due to bladder cancer, assessed up to 5 years
Safety Issue:
Description:
Measure:Quality of life
Time Frame:Baseline up to 5 years
Safety Issue:
Description:Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)-C30. Will be examined using linear mixed models with patient considered as the random effect. The baseline physical function score and the stratification factors will be included in the regression model as adjustment covariates.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:National Cancer Institute (NCI)

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