Combination Chemotherapy and Radiation Therapy Plus Surgery in Treating Patients With Advanced Ca… (NCT00020345) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy and Radiation Therapy Plus Surgery in Treating Patients With Advanced Cancer of the Pancreas
United StatesStarted 2000-09
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways, such as directly into the abdomen, and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy plus surgery in treating patients who have advanced cancer of the pancreas.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampullae of vater not amenable to curative surgery Metastases confined to abdominal cavity May include peripancreatic lymph nodes, peritoneal carcinomatosis, and hepatic metastases Extrapancreatic disease must be resectable Must have progressive disease if received any prior therapy No distant metastases, including lung or bone metastases --Prior/Concurrent Therapy-- Biologic therapy: No concurrent immunotherapy for pancreatic cancer Chemotherapy: No prior gemcitabine or fluorouracil Endocrine therapy: No concurrent hormonal therapy for pancreatic cancer Radiotherapy: No prior radiotherapy for pancreatic cancer No prior abdominal or pelvic radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior anticancer therapy and recovered --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT less than 4 times upper limit of normal No active hepatitis Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No significant reversible ischemic changes in wall motion or perfusion with stress (correction using angiography and angioplasty allowed) No significant resting left ventricle dysfunction No unstable angina No …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00020345
SponsorNational Institutes of Health Clinical Center (CC)