Status:
WITHDRAWN
Randomized Phase III of PRRT Versus Interferon
Lead Sponsor:
Jules Bordet Institute
Conditions:
Gastro-intestinal Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the benefit of 177Lu-DOTATATE versus interferon α-2b in patients with progressive, unresectable, non-pancreatic gastrointestinal neuroendocrine tumors resistant ...
Detailed Description
This is a phase III study of Peptid Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE versus Interferon α-2b. Objectives of the study: 1. To assess the benefit of 177Lu-DOTATATE versus interf...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 yrs).
- Histology-proven non-pancreatic gastrointestinal NETs.
- Disease progression under SSAs (SSAs-resistant disease). Disease progression must be documented with at least one of the following:
- Radiological disease progression (according to RECIST 1.1) on an MRI or CT over the last 12 months.
- Disease progression on a somatostatin receptor-imaging (PET/CT or SPECT/CT) over the last 12 months (apparition of new lesion(s) or increase in the transaxial plane diameter of more than 30% on the same imaging modality).
- There should be at least one target lesion. A target lesion should fulfill all the following criteria:
- Uptake higher than the physiological liver uptake on the baseline 68Ga-DOTATATE PET/CT
- Longest transaxial plane diameter ≥ 20mm measured on the CT or MRI;
- Not previously irradiated.
- Long-acting SSAs must be discontinued at least 4 weeks before the study treatment start date and, if needed, switched to short-acting analogues which must be stopped 48h before the treatment date.
- Adequate renal function with GFR ≥ 50 mL/min/1.73m2 (evaluated by 51Cr-EDTA test).
- Adequate bone marrow function with:
- Hemoglobin ≥ 9 g/dL;
- Neutrophil ≥ 1.5·109/L;
- Platelet count ≥ 100·109/L.
- Adequate liver function with:
- Total Bilirubin ≤ 2xULN;
- Transaminases (AST and ALT) ≤ 5xULN;
- Serum albumin \> 3.0 g/dL with normal prothrombin time (\>70%) unless for patients under coumarin anticoagulation therapy.
- ECOG Performance Status ≤ 1.
- Women of childbearing potential and men with partners of childbearing potential must agree to use a highly effective form of contraception for the duration of study participation and up to six months after the end of the treatment. A pregnancy test (serum) must be performed within 2 weeks prior to inclusion for every female patient of childbearing potential and it must be negative.
- Patient's written informed consent obtained prior to any study specific procedure.
- All necessary baseline procedures should be performed within 2 weeks prior to randomization date.
Exclusion
- Resectable tumor with curative intent.
- Any major surgery within the last 6 weeks prior to inclusion in the study.
- Radiotherapy, chemotherapy, embolization, mammalian target of rapamycin (mTOR)-inhibitors, receptor tyrosine-kinase inhibitors or other investigational therapy within 12 weeks prior to inclusion in the study.
- Previous PRRT or MIBG treatment.
- Treatment with interferon 12 months prior to inclusion in the study.
- Presence of non-benign 18FDG-positive lesions (higher than 2 x normal liver (or thoracic aorta uptake -SUVmax- in case of liver involvement)) without significant 68Ga-DOTATATE uptake.
- Uncontrolled congestive heart failure (NYHA stade ≥ 2).
- Diffuse bone marrow infiltration on the baseline 68Ga-DOTATATE PET/CT confirmed by MRI.
- Prior external beam radiotherapy on kidneys or on more than 25% of bone marrow.
- Patients with known uncontrolled brain metastases.
- History of other active malignant disease or clinical remission less than 5 years (except in case of non melanoma skin cancer or in situ cervical carcinoma).
- Known autoimmune hepatitis.
- Patients after organ transplantation under immunosuppressive therapy.
- Patients with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the investigator's opinion, may interfere with completion of the study.
- Hypersensitivity to interferon α-2b or to any component of the product.
- Pregnant or lactating patients.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01860742
Start Date
December 1 2014
End Date
October 1 2016
Last Update
April 5 2016
Active Locations (2)
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1
Jules Bordet Institute
Brussels, Belgium, B-1000
2
UZ Leuven
Leuven, Belgium, B-3000