Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Conditions

• Metastatic Malignant Neoplasm in the Liver
• Pancreatic Neuroendocrine Tumor
• Stage I Pancreatic Neuroendocrine Tumor AJCC v8
• Stage II Pancreatic Neuroendocrine Tumor AJCC v8
• Stage III Pancreatic Neuroendocrine Tumor AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Capecitabine — DRUG
  Given PO
• Temozolomide — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

May 5, 2022

Status verified

Dec 2025

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

141 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (capecitabine, temozolomide)
  Patients receive capecitabine PO BID on days 1-14 and temozolomide PO once QD on days 10-14. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
• No Intervention: Arm II (surveillance)
  Patients undergo surveillance with no active treatment.

Primary Outcome Measure

Recurrence-free survival (RFS) [ Time Frame: From date of randomization to progression/recurrence or death from any cause, assessed up to 5 years ]

Locations (446)

Find similar trials in Anchorage, AK

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