Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomizā¦ (NCT02230176) | Clinical Trial Compass
CompletedPhase 2
Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II
France84 participantsStarted 2015-02
Plain-language summary
This study is the first randomized, open-label, national, multicenter, phase II study assessing the efficacy and safety of OCLU in subjects with pretreated progressive pancreatic, inoperable, somatostatin receptor positive, well differentiated pancreatic neuroendocrine tumors (WDpNET). Subjects must have experienced documented progression of disease within 1 year prior to the start of the study. The control group of patients receiving Sutent will be used as internal control to assess the hypothesis of 12 months PFS equal to 35% in patients receiving Sutent.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically proven and reviewed well differentiated malignant pancreatic sporadic NET Metastatic disease not amenable to surgical resection
* All target lesions (lesions measurable and non-measurable according to the RECIST 1.1 criteria), of a size ā„ 15 mm, twice the spatial resolution of the somatostatin receptor scintigraphy (SRS), should be positive (grade of uptake at SRSā„ 2, equal to the physiologic liver uptake) within 24 weeks prior to enrollment. Negative target lesions are acceptable if below 15mm.
* Post first line whatever the type of systemic therapy: cytotoxic chemotherapy or everolimus or somatostatine analogsā¦ Only one line of cytotoxic chemotherapy is authorized.
* Evaluable disease according to RECIST 1.1 criteria (Appendix 2)
* Progressing disease within 12 months prior to randomization according to RECIST 1.1 criteria ;
* ECOG performance status 0-2 (appendix 9)
* Life expectancy ā„ 6 months as prognosticated by the physician
* Age ā„ 18 years, no superior limit
* Adequate bone marrow reserve (Hb \> 8, neutrophils ā„ 1500/mmĀ³ and platelets ā„80.000/mm\^3)
* Effective contraception in pre-menopausal female and male patients during and for at least 6 months post-treatment.
* PatientĀ“s signed written informed consent
* Ability to comply with the protocol procedures
* Ability to take oral medication
* Patient affiliated to a social security system or beneficiary of the same.
Exclusion Criteria:
* Large or small cell-poorly differentiatedā¦