Clinical Trials /

Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer

NCT03594630

Description:

This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.

Related Conditions:
  • Rectal Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer
  • Official Title: Organ Preservation With Active Surveillance After Chemoradiation in Rectal Cancer (OPTION)

Clinical Trial IDs

  • ORG STUDY ID: 2016-0549
  • SECONDARY ID: NCI-2018-01142
  • SECONDARY ID: 2016-0549
  • SECONDARY ID: P30CA016672
  • NCT ID: NCT03594630

Conditions

  • Rectal Adenocarcinoma
  • Stage II Rectal Cancer AJCC v8
  • Stage IIA Rectal Cancer AJCC v8
  • Stage IIB Rectal Cancer AJCC v8
  • Stage IIC Rectal Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8
  • Stage IIIA Rectal Cancer AJCC v8
  • Stage IIIB Rectal Cancer AJCC v8
  • Stage IIIC Rectal Cancer AJCC v8

Interventions

DrugSynonymsArms
ChemotherapyChemo, Chemotherapy (NOS), Chemotherapy, Cancer, GeneralGroup II (active surveillance)

Purpose

This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To quantify the rates of organ preservation and tumor regrowth with non-operative
      management of locally advanced rectal cancer in patients achieving a clinical complete
      response (cCR).

      SECONDARY OBJECTIVES:

      I. To correlate clinical, radiographic, and pathologic findings after neoadjuvant therapy for
      rectal cancer.

      II. To determine the impact of active surveillance with deferral of surgery on oncologic
      outcomes.

      III. To assess decision quality for patients with rectal cancer facing multiple treatment
      options.

      IV. To explore the impact of patient-provider communication on patient decisions for surgical
      versus nonsurgical treatment decision for rectal cancer.

      V. To assess safety of deferral of surgery in distal rectal cancer patients with possibility
      of cohort expansion to more proximal locally advanced rectal cancer patients.

      CORRELATIVE OBJECTIVES:

      I. Obtain tissue to monitor treatment response and any future biomarker analyses

      OUTLINE: Participants are assigned to 1 of 2 groups.

      GROUP I: Participants who have achieved clinical complete response undergo standard surgical
      resection.

      GROUP II: Participants who have achieved clinical complete response receive active
      surveillance and consolidated chemotherapy for up to 4 months in the absence of disease
      progression or unacceptable toxicity. Participants with incomplete response or regrowth of
      tumor, undergo surgical resection as in Group I.

      After the completion of study treatment, participants in Group I are followed up at 6 and 12
      months, and then once a year for up to 3 years. Participants in Group II are followed up
      every 3 months for 18 months, every 6 months for 2 years, and then every year for up to 3
      years.
    

Trial Arms

NameTypeDescriptionInterventions
Group I (surgical resection)Active ComparatorParticipants who have achieved clinical complete response undergo standard surgical resection.
    Group II (active surveillance)ExperimentalParticipants who have achieved clinical complete response receive active surveillance and consolidated chemotherapy for up to 4 months in the absence of disease progression or unacceptable toxicity. Participants with incomplete response or regrowth of tumor, undergo surgical resection as in Group I.
    • Chemotherapy

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically confirmed diagnosis of rectal adenocarcinoma
    
              -  Eligible for curative resection of rectal adenocarcinoma
    
              -  Rectal tumor location =< 12 cm from the anal verge as determined by endoscopy or
                 magnetic resonance imaging (MRI) (if endoscopy report is not available or deemed
                 inadequate my treating oncologist)
    
              -  Nodal involvement confined to the radiation field
    
              -  Radiologically measurable or clinically evaluable disease as defined in the protocol
    
              -  Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1 or 2
    
              -  Clinical Stage: Stage II and III. N2 disease is to be estimated as four or more lymph
                 nodes that are >= 10 mm. Clinical staging should be estimated based on the combination
                 of the following assessments: physical exam by the primary surgeon including digital
                 rectal exam (DRE), computed tomography (CT) or positron emission tomography (PET)/CT
                 scan of the chest/abdomen/pelvis and a pelvic MRI. If a pelvic MRI is performed, it is
                 acceptable to perform CT of the chest/abdomen, omitting CT imaging of the pelvis.
                 PET/CT is optional.
    
              -  No known contraindication to standard (fluoropyrimidine-based) pelvic chemoradiation
                 (e.g. dihydropyrimidine dehydrogenase [DPD] deficiency)
    
              -  Patient of child-bearing potential is willing to employ adequate contraception during
                 treatment and after treatment, as directed by treating clinical team
    
              -  Willing to provide written informed consent
    
              -  Willing to return to enrolling medical site for all study assessments
    
            Exclusion Criteria:
    
              -  Diagnosis of inflammatory bowel disease (IBD)
    
              -  Diagnosis of MSI-H colorectal cancer at time of consent
    
              -  Recurrent rectal cancer
    
              -  Tumor is causing symptomatic bowel obstruction (patients who have diverting ostomy are
                 eligible)
    
              -  Any prior pelvic radiation
    
              -  Other invasive malignancy undergoing active treatment. Patients receiving prior
                 treatment that precludes standard chemoradiation or ability to receive
                 consolidation/adjuvant chemotherapy will be excluded from survival analyses
    
              -  Patients unwilling or unable to undergo pelvic MRI
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Overall organ preservation rate
    Time Frame:At 12 months
    Safety Issue:
    Description:The study will estimate overall organ preservation rate at 12 months and the corresponding 95% confidence interval (95% CI). The exact confidence interval will be computed when observed number of events is limited. The 12-month organ preservation rate corresponds to the proportion of patients alive and not having surgery within 12 months. The study will use Kaplan-Meier methods to estimate probability of overall organ preservation at 12 months at 12 months for all patients and for deferral patients respectively.

    Secondary Outcome Measures

    Measure:Decision quality assessment determined by European Organization for Treatment and Research of Cancer Quality of Life Questionnaire (EORTC-QLQ30+CR29)
    Time Frame:Up to 3 years
    Safety Issue:
    Description:The aspects of the patient's decision making process will be documented and studied to assess what criteria, including the impact of patient-provider communication, seem to be driving the patients' decision to delay surgery or not. The decision evaluation questions such as decision quality survey, satisfaction with decision and anticipated regret questionnaire will be documented and summarized. Descriptive statistics will be used to summarize continuous variables and frequency and percentage will be used to tabulate categorical variables. The study will summarize quality of life measures, toxicity, surgical success rates, clinical, radiographic and pathologic findings, and exploratory comparisons among patient cohorts will be done.
    Measure:Overall survival (OS)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:Overall survival will be estimated using Kaplan-Meier method.
    Measure:Regression-free survival (RFS)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:Regression-free survival will be estimated using Kaplan-Meier method.
    Measure:Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Surgical success rates
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Radiographic Findings
    Time Frame:Up to 5 years
    Safety Issue:
    Description:MRI performed.
    Measure:Pathologic Findings
    Time Frame:Up to 5 years
    Safety Issue:
    Description:Blood and tissue collected at various time points.

    Details

    Phase:Early Phase 1
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:M.D. Anderson Cancer Center

    Last Updated