Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors (NCT05040360)
๐ฉบ Plain-English Summary (8th-Grade Level)
This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (30 items) and avoid the listed exclusions (12 items).
Location: Anchorage Associates in Radiation Medicine โ Anchorage, Alaska
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participants must not have unresected or unablated metastatic disease
- Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis
- Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted
- Participants must not have received somatostatin analogs after surgery
- Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed
- Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
- Participants must not have known absorption issues that would limit the ability to absorb study agents
- Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration
- Participants must not have active or uncontrolled infection
- Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator
- Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (448 Sites)
- Anchorage Associates in Radiation Medicine โ Anchorage, Alaska
- Anchorage Radiation Therapy Center โ Anchorage, Alaska
- Alaska Breast Care and Surgery LLC โ Anchorage, Alaska
- Alaska Oncology and Hematology LLC โ Anchorage, Alaska
- Alaska Women's Cancer Care โ Anchorage, Alaska
- Anchorage Oncology Centre โ Anchorage, Alaska
- Katmai Oncology Group โ Anchorage, Alaska
- Providence Alaska Medical Center โ Anchorage, Alaska
- Fairbanks Memorial Hospital โ Fairbanks, Alaska
- Banner MD Anderson Cancer Center โ Gilbert, Arizona
- Kingman Regional Medical Center โ Kingman, Arizona
- Cancer Center at Saint Joseph's โ Phoenix, Arizona
- Mayo Clinic Hospital in Arizona โ Phoenix, Arizona
- Banner University Medical Center - Tucson โ Tucson, Arizona
- University of Arizona Cancer Center-North Campus โ Tucson, Arizona
- Mercy Hospital Fort Smith โ Fort Smith, Arkansas
- CARTI Cancer Center โ Little Rock, Arkansas
- Mission Hope Medical Oncology - Arroyo Grande โ Arroyo Grande, California
- PCR Oncology โ Arroyo Grande, California
- Tower Cancer Research Foundation โ Beverly Hills, California
- Keck Medicine of USC Buena Park โ Buena Park, California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center โ Burbank, California
- Mercy Cancer Center - Carmichael โ Carmichael, California
- Mercy San Juan Medical Center โ Carmichael, California
- Epic Care-Dublin โ Dublin, California
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.