Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
Launched by SWOG CANCER RESEARCH NETWORK · Sep 2, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how effective two chemotherapy drugs, capecitabine and temozolomide, are when given to patients after they have had surgery for a specific type of cancer called high-risk well-differentiated pancreatic neuroendocrine tumors. The goal is to see if these drugs can help prevent or delay the cancer from coming back. The study is currently recruiting participants who are at least 18 years old and have had their tumors surgically removed within the last 14 to 90 days. To qualify, patients must have certain test results showing their cancer is high-risk, and they should not have any signs of cancer spreading to other parts of the body.
Participants in the trial will take these chemotherapy pills after surgery, and they will be monitored closely through regular check-ups and scans to see how well the treatment is working. It’s important to know that this study is not for everyone; certain health conditions and previous treatments may exclude someone from participating. Those interested will need to provide informed consent, which means they will understand the nature of the trial and agree to participate. This trial is an opportunity to potentially improve outcomes for patients with this challenging type of cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 90 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam
- • Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report
- • Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be \>= 3% and =\< 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and/or the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria
- * Participants with localized resected pNETS must have a Zaidi score of \>= 3 derived by the following factors and points:
- * 1 point; symptomatic tumor defined as one of the following:
- • Gastrointestinal bleed
- • Jaundice
- • Gastrointestinal obstruction
- • Pain from primary tumor prior to surgical resection
- • Pancreatitis
- • 2 points; primary pancreas tumor size \> 2 cm
- • 1 point; Ki-67 3% to 20%
- • 1 point; lymph node positivity = 1
- • 6 points; Ki-67 21% to 55%
- • Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection
- • Participants must have recovered from effects of surgery as determined by the treating investigator
- • Participants must be \>= 18 years old
- • Participants must have Zubrod performance status of 0-2
- • Participants must have a complete medical history and physical exam within 28 days prior to registration
- • Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to registration)
- • Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration)
- • Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration)
- • Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration)
- • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 28 days prior to registration)
- • Serum creatinine =\< 1.5 x institutional ULN (within 28 days prior to registration)
- • Calculated creatinine clearance \>= 50 ml/min (within 28 days prior to registration)
- • Participants must be able to swallow pills
- • Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol
- • No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years
- • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- 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
About Swog Cancer Research Network
The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
New Haven, Connecticut, United States
Cleveland, Ohio, United States
Charleston, South Carolina, United States
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Mount Sterling, Kentucky, United States
Lebanon, New Hampshire, United States
Alcoa, Tennessee, United States
Centralia, Illinois, United States
Dayton, Ohio, United States
Danville, Illinois, United States
Guilford, Connecticut, United States
Greenville, Ohio, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Ames, Iowa, United States
Patients applied
Trial Officials
Heloisa P Soares
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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