Testing Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05040360

Provider View

This study is exploring whether using chemotherapy drugs capecitabine and temozolomide after surgery can help prevent or delay the return of high-risk pancreatic neuroendocrine tumors.

Patient Parameters

Program Overview

This phase II clinical trial is investigating the effects of chemotherapy drugs, capecitabine and temozolomide, when given after surgery to patients with high-risk pancreatic neuroendocrine tumors. These drugs work by stopping the growth of cancer cells in different ways, such as killing the cells or preventing them from dividing or spreading. The study aims to see if this treatment can help prevent or delay the cancer from coming back.

Description

The main goal of this study is to see how long patients can remain free of cancer after surgery when treated with capecitabine and temozolomide (CAPTEM) compared to just being observed without active treatment.

Secondary goals include evaluating overall survival rates and the safety of the CAPTEM treatment compared to observation. The study also aims to collect tissue samples for future research.

Participants are randomly assigned to one of two groups:

  • Group 1: Patients take capecitabine by mouth twice a day for 14 days and temozolomide once a day for 5 days, repeating this cycle every 28 days for up to 4 cycles, unless the cancer progresses or side effects become unacceptable.
  • Group 2: Patients are monitored with regular check-ups but do not receive active treatment.

After finishing the study treatment, patients will have follow-up visits every 6 months for 3 years, and then once a year until 5 years after starting the study.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was surgically removed 14 to 90 days before joining the study.
  • Must have a scan within 90 days before joining the study showing no spread of cancer.
  • Surgery must have removed all visible cancer, with a margin of healthy tissue (R0 or R1 resection).
  • Ki-67 test results must be between 3% and 55%.
  • Must have a Zaidi score of 3 or higher, based on factors like tumor symptoms, size, and Ki-67 levels.
  • May have had up to 5 liver metastases removed or treated at the time of pNET surgery.
  • Must have recovered from surgery.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Must have a complete medical history and physical exam within 28 days before joining the study.
  • Must meet specific blood count and organ function criteria.
  • Must be able to swallow pills and tolerate imaging tests with contrast.
  • Must not have any other active cancer, except for certain treated skin or cervical cancers, or cancers in remission for two years.
  • Must understand the study and agree to sign informed consent.

Exclusion Criteria

  • Must not have any remaining or untreated metastatic cancer.
  • Must not have cancer spread to the brain or spinal fluid.
  • Must not have received prior chemotherapy for pancreatic neuroendocrine tumor, except for somatostatin analogs before surgery.
  • Must not be planning to take warfarin during the study.
  • Must not have allergies to temozolomide or capecitabine.
  • Must not have absorption issues affecting medication intake.
  • Must not have had recent serious heart events.
  • Must not have active infections or serious medical or psychiatric conditions.
  • Must not be pregnant and must agree to use effective contraception if of reproductive potential.

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