Clinical Trials /

Optimizing the Interval Between Cycles of PRRT With 177lu-dotatate in sstr2 Positive Tumors

NCT03454763

Description:

Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT With 177lu-dotatate

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Optimizing the Interval Between Cycles of PRRT With 177lu-dotatate in sstr2 Positive Tumors
  • Official Title: Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT With 177lu-dotatate

Clinical Trial IDs

  • ORG STUDY ID: IRST100.26
  • NCT ID: NCT03454763

Conditions

  • Neuroendocrine Tumors

Interventions

DrugSynonymsArms
PRRT every 5 weeksArm A, Intensive
PRRT every 8-10 weeksArm B, Non Intensive

Purpose

Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT With 177lu-dotatate

Detailed Description

      The main objective of this randomized phase II comparative study is to evaluate the
      Progression Free survival (PFS) and the safety as co-primary objective of two different
      schedule of administrations of 177lu-dotatate: intensive (every 5 weeks) vs no intensive
      (every 8-10 weeks) The secondary objectives are DCR, the late toxicity, OS and dosimetry.
      Patients with any tumor histotype documented as sst2-positive in pre-study period will be
      enrolled in the study.

      The study will include a total of 618 planned patients. They will be randomly assigned to
      receive 5 cycles of PRRT at intervals of 5 or 8-10 weeks between cycles.
    

Trial Arms

NameTypeDescriptionInterventions
Arm A, IntensiveExperimentalArm A, Intensive every 5 weeks
  • PRRT every 5 weeks
Arm B, Non IntensiveExperimentalArm B, Non Intensive every 8-10 weeks
  • PRRT every 8-10 weeks

Eligibility Criteria

        Inclusion Criteria:

          1. Age >18 years.

          2. Patients must have histologically or cytologically confirmation of neuroendocrine
             tumors or any other tumor histotype documented as sst2-positive), that may benefit
             from receptor radionuclide therapy and for which there aren't any other effective
             treatments. For cerebral sst2-positive tumors, if biopsy is no feasible for technical
             reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest
             oncological lesion confirming the 68Ga PET-CT dota-peptide SSTr2 positivity..

          3. Measurable disease according to RECIST 1.1.criteria also patients without measurable
             but with evaluable disease disease can be enrolled.

          4. Any disease stage is allowed. Patients with documented disease will be admitted to
             therapeutic phase only if the diagnostic OctreoScan (the tumour uptake will be
             evaluated with a 3-grade scale, where 1 = liver uptake, 2 > liver uptake and < kidney
             uptake and 3 > kidney uptake: only tumour uptakes grade 2 and 3 will be considered for
             therapy) and/or Positron Emission Tomography (PET)/CT 68Ga-peptide images demonstrate
             a significant uptake in the tumour.

          5. Patients with progressive disease in pre-study period (PD within the last 12 months),
             refractory to conventional standard treatments; clinical progression is allowed

          6. Patients with or without concurrent therapy with somatostatin analogs

          7. Life expectancy of greater than 6 months.

          8. Eastern Cooperative Oncology Group (ECOG) performance status <2

          9. Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absolute
             neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin ≤1.5 X
             upper normal limit (UNL) , alanine aminotransferase ( ALT) and Aspartate
             aminotransferase (AST) <2.5 X UNL (< 5 X UNL in presence of liver metastases,
             creatinine < 2 mg/dL.

         10. If female of childbearing potential highly effective birth control methods, according
             to guideline "Recommendation related to contraception and pregnancy testing in
             clinical trials", (2014_09_15 section 4.1) are mandatory.

         11. Participant is willing and able to give informed consent for participation in the
             study.

        Exclusion Criteria:

          1. Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and
             treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy.

          2. Patients treated with previous radio-metabolic therapy with an adsorbed dose to the
             kidney more than 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of
             dosimetry (13).

          3. All acute toxic effects of any prior therapy (including surgery radiation therapy,
             chemotherapy) must have resolved to a grade ≤ 1 according to National Cancer Institute
             Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE)

          4. ECOG performance status >2

          5. Participation in another clinical trial with any investigational agents within 30 days
             prior to study screening.

          6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          7. Assessed bone marrow invasion > 50% (with Bone Marrow biopsy or instrumental exams i.e
             bone scan or CT or MRI)

          8. Pregnant or breastfeeding women are excluded from the present study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:PFS
Time Frame:up to 5 years
Safety Issue:
Description:Progression free survival is defined as the time from the randomization date to the date of first observation of documented disease progression or death due to any cause

Secondary Outcome Measures

Measure:DCR
Time Frame:up to 5 years
Safety Issue:
Description:Disease Control Rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response and stable disease for at least 12 weeks from therapy start. DCR will be evaluated using the new international criteria proposed by the Version 1.1 Response Evaluation Criteria in Solid Tumors (RECIST)
Measure:OS
Time Frame:up to 5 years
Safety Issue:
Description:Overall Survival (OS) is defined as the time from treatment start to the time of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Trial Keywords

  • sst2-positive tumors
  • Neuroendocrine Tumors
  • radiolabelled somatostatin analogues (PRRT)

Last Updated

April 20, 2020