Randomized Phase III of PRRT Versus Interferon (CASTOR)
|ClinicalTrials.gov Identifier: NCT01860742|
Recruitment Status : Withdrawn
First Posted : May 23, 2013
Last Update Posted : April 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastro-intestinal Neuroendocrine Tumors||Drug: Interferon alpha-2b Drug: 177Lu-DOTATATE||Phase 3|
This is a phase III study of Peptid Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE versus Interferon α-2b.
Objectives of the study:
- To assess the benefit of 177Lu-DOTATATE versus interferon α-2b in patients with progressive, unresectable,non-pancreatic gastrointestinal neuroendocrine tumors, resistant to therapy with somatostatin analogues, in terms of disease control.
- To assess efficacy and safety parameters of both treatment arms and the predictive value of tumor 68Ga-DOTATATE PET/CT and 18FDG PET/CT uptake at baseline, at mid (+/- 16th week) and end (+/- 32th week) of treatment in both arms.
In the interferon arm: 5000000 Units of interferon will be administered subcutaneously preferentially in the evening three times a week (every other day) until disease progression.
In the 177Lu-octreotate arm: Treatment will consist of 177Lu-DOTATATE intravenous injections fractionated in fixed activities of 7,4 GigaBecquerel (200mCi) (+/- 5%), given every 8 (+/- 1) weeks with simultaneous nephroprotective infusion of an amino acid solution. (Before amino acid nephroprotection solution, ondansetron, methylprednisolone and metoclopramid, are given in infusions in order to prevent nausea or vomiting). Approximately 30 min after the beginning of the aminoacid solution, 177Lu-octreotate is injected via a second side-line over 15-30 minutes. The amino acid infusion is continued at the same rate until end (total infusion time: 4-6 hours).
In total, 4 injections of 177Lu-DOTATATE are planned. However, in respect of the absorded dose limits of critical organs(kidneys and bone marrow), the 4th 177Lu-DOTATATE injection will be tailored with a minimal administered activity of 4,6 GigaBecquerel.
Treatment efficacy will be assessed on a patient-basis using RECIST 1.1 and by Progression Free Survival. The value of tumor 68Ga-DOTATATE PET/CT and 18FDG PET/CT uptake as predicting imaging biomarkers will also be assessed in both arms.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Carcinoid Tumors After Failure of Somatostatin Analogs: a Randomized Phase III of Octreotide Lutate Peptid Receptor Radionuclide Therapy (PRRT) Versus Interferon α-2b|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2016|
Active Comparator: Interferon alpha-2b
Interferon α-2b in a dose of 5000000 Units administered subcutaneously every second day until progression or unacceptable adverse event from a clinical or a patient point of view.
Drug: Interferon alpha-2b
Interferon α-2b in a dose of 5000000 Units administered subcutaneously every second day
Other Name: Intron A
Active Comparator: 177Lu-DOTATATE
intravenous injection of 177Lu-octreotate with simultaneous infusion of an aminoacid solution
177Lu-octreotate infusions in fixed activities of 7,4 GigaBecqurel each, given 8-11 weeks apart, injected intravenously with simultaneous infusion of an amino acid solution
- Progression Free Survival (PFS) [ Time Frame: 3 years [Anticipated] ]
PFS is defined by the time between treatment initiation and the first of the following events:
- Disease progression according to RECIST 1.1;
- Death of the patient from any cause;
- Appearance of confirmed new lesion(s) on 68Ga-DOTATATE PET/CT or 18FDG PET/CT.
- Treatment response according to RECIST 1.1 (Response Evaluation Criteria In Solid Tumors) [ Time Frame: 3 years [Anticipated] ]
- Adverse events according to Common Terminology Criteria for Adverse Events version 4.03 (CTC 4.03-WHO criteria) [ Time Frame: 3 years [Anticipated] ]
- Tumor 18FDG PET/CT and 68Ga-octreotate PET/CT uptake at baseline, at mid and end of treatment [ Time Frame: 3 years [Anticipated] ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860742
|Jules Bordet Institute|
|Brussels, Belgium, B-1000|
|Leuven, Belgium, B-3000|
|Principal Investigator:||Patrick Flamen, M.D., Ph.D.||Jules Bordet Institute|
|Principal Investigator:||Christophe Deroose, M.D., Ph.D.||UZ Leuven|