Status:
WITHDRAWN
177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Neuroendocrine Tumors
Carcinoid Tumor
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
This study is to assess if personalized peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATOC results in fewer adverse events than standard PRRT. Subjects will be randomized to either receiv...
Detailed Description
Overall, 200 subjects will be randomized (1:1 randomization ratio) to receive standard injected activities of 177Lu-DOTATOC PRRT or personalized injection of 177Lu-DOTATOC PRRT. Randomization will be ...
Eligibility Criteria
Inclusion
- Able to provide written informed consent
- Age greater than or equal to 19 years
- Biopsy-proven, well-differentiated grade 1 - 3 NET
- Gastroenteropancreatic tumors (e.g. carcinoids, gastrinoma, insulinoma, glucagonoma, VIPoma, etc.), functioning and non-functioning
- Sympathoadrenal system tumors (phaeochromocytoma, paraganglioma)
- Pulmonary NET, functioning and non-functioning
- Easter Cooperative Oncology Group (ECOG) ≤ 2
- Ki67 ≤ 55%
- Progressive disease demonstrated by RECIST 1.1 criteria within the 6 months preceding the study.
- Patients with other evidence of progressive disease that is not demonstrated on CT (like rising biomarkers) may be included, at the discretion of the Tumour Review Board.
- If response to other treatments is considered adequate according to other criteria, the Tumour Review Board may consider excluding the patient from participation in the study.
- Tumour Review Board confirmation of suitability to proceed to PRRT treatment and enrollment in this trial.
- Positive PET SSR imaging (Krenning score 2 or higher) in previous 6 months (68Ga-DOTATOC, 68Ga-DOTATATE, 18F-AmBF3-TATE). If PET SSR imaging is not available 111In-penetreotide scintigraphy (Octreotide scan) is acceptable.
- Adequate laboratory parameters within two weeks of enrollment
- Kidneys
- Serum creatinine ≤ 150 µmol/L
- GFR ≥ 40 ml/min (using plasma clearance values)
- Marrow
- Hemoglobin ≥ 80 g/L
- WBC ≥ 2 x 109/L
- Platelets ≥ 75 x 109/L
- Liver
- Total bilirubin ≤ 3 x upper limit of normal (ULN)
- ALT ≤ 3 x ULN or ≤ 5 x ULN if liver metastasis
- Alkaline phosphatase ≤ 3 x ULN or ≤ 5 x ULN if liver metastasis
- Subject's ability to comply with scheduled visits, treatment plans, laboratory tests, imaging tests, and other procedures required as detailed in the protocol.
Exclusion
- Women and men of childbearing potential Procreation
- Women: pregnancy test done before enrollment before each treatment cycle. And subject must use adequate contraception for the duration of therapy, be surgically sterile, or post-menopausal.
- Men: must be surgically sterile or use adequate contraception for the duration of the therapy.
- Patient with another non-cutaneous (excluding melanoma) active cancer requiring therapeutic intervention.
- Curative medical or surgical treatment, local liver embolization, or debulking are appropriate options.
- Life expectancy is less than 12 weeks.
- Radiotherapy to target lesions ≤ 12 weeks ago or to more than 25% of bone marrow.
- PRRT at any time prior to randomization in this study.
- Systemic therapy (chemotherapy) within 4 weeks of PRRT and other locoregional therapies (radioisotope, embolization) within 12 weeks prior to enrollment. Ongoing use of somatostatin analogs for control of symptoms is allowed.
- Known brain metastases (unless treated and stable for more than 3 months).
- Co-morbidities that could, in the opinion of the PI, interfere with safe delivery of PRRT (like urinary incontinence, psychiatric illness), uncontrolled congestive heart failure (NYHA II, III, IV)
- Breastfeeding (if patients elect to discontinue breast feeding, they can participate in the trial).
Key Trial Info
Start Date :
January 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2031
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04915144
Start Date
January 15 2023
End Date
December 31 2031
Last Update
February 21 2023
Active Locations (1)
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1
BC Cancer
Vancouver, British Columbia, Canada, V5Z 4E6