Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors, the ComPareNET Trial

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Primary completion moved earlier from Mar 31, 2028 to Oct 1, 2027 Show 4 more changesShow less
    • Study completion moved earlier from Oct 1, 2033 to Apr 1, 2033
    • Secondary endpoints: details revised at 7 of 10 entries
    • Site details revised at 7 of 171 sites
    • Eligibility criteria expanded, about 5 words
  2. Eligibility criteria shortened, about 170 words
    • Study description expanded, about 105 words
    • Study title expanded, about 3 words
    v15
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 198 to confirmed 31
    • Study sites: 172 to 171
    v14
  4. Start date: Mar 16, 2022 to Feb 16, 2023
    • Study completion date: Oct 2033 to Oct 1, 2033
    • Site contacts updated at 155 of 172 sites
    v13
  5. Study sites revised (172)v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 171 to 172v11
  2. Study sites: 150 to 171v10
  3. Study sites revised (150)v9
  4. Study sites: 149 to 150v8
  5. Study sites: 120 to 149v7
  6. Study sites: 118 to 120v6
  7. Study sites: 116 to 118v5
  8. Study sites: 66 to 116v4
  9. Study sites: 65 to 66v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 65
    • Start date changed from estimate of Mar 2022 to Mar 16, 2022
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial compares the effect of combination therapy with capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or that cannot be removed by surgery (unresectable). Temozolomide and capecitabine are considered chemotherapy drugs. Temozolomide is in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid and may kill cancer cells. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate, builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Treatment with lutetium Lu 177 dotatate may be more effective than combination therapy with temozolomide and capecitabine in shrinking or stabilizing cancer in patients with advanced or unresectable neuroendocrine tumors.
Trial Details
NCT Number NCT05247905
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Pancreatic Neuroendocrine Tumor, Unresectable Pancreatic Neuroendocrine Carcinoma
Related terms Adenoma, Islet Cell
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov