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Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas Clinical research trials and Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas. Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas  Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
For Condition: stage 2 pancreatic cancer,adenocarcinoma of the pancreas,stage 1 pancreatic cancer,stage 3 pancreatic cancer
Status: No longer recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Surgery to remove the pancreas, some of the small intestine, and lymph nodes may be more effective treatment for cancer of the pancreas than surgery to remove the pancreas and some of the small intestine alone. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery, radiation therapy, and chemotherapy may be an effective treatment for cancer of the pancreas. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the pancreas and a portion of the small intestine with or without removing lymph nodes, followed by radiation therapy and chemotherapy, in treating patients with cancer of the pancreas.
Details: OBJECTIVES: - Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma undergoing extended versus standard pancreatoduodenectomy. OUTLINE: Patients are randomized to undergo standard pancreatoduodenectomy (PD) or PD with extended lymph node resection after an exploratory laparotomy. Patients receive adjuvant chemoradiation therapy 4-6 weeks after surgery, if no metastases are evident. Radiation therapy is given every week for 5 weeks. Fluorouracil/leucovorin calcium is administered by rapid IV push daily within 2 hours of radiation on days 1-4 of week 1 and days 29-31 of week 5. Patients are followed every 4 months for the first year, then every 6 months for the next 2 years. PROJECTED ACCRUAL: 50 patients will be accrued per group for a total of 100 patients.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically proven adenocarcinoma of the exocrine pancreas excluding periampullary cancer - Resectable malignancy must be located in a region that can be encompassed by a radiation port of 20 x 20 cm - No evidence of extranodal metastatic disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Not specified Renal: - Bilateral renal function as demonstrated by excretory urogram (IVP) or abdominal CT scan with contrast OR - Greater than 2/3 of one functioning kidney must be shielded during radiation therapy Other: - Must have adequate oral nutrition (greater than 1200 calories daily) - Greater than 5 years since prior malignancy except: - Squamous cell skin cancer - Basal cell skin cancer - In situ cervical cancer - Not pregnant or lactating - Patients of reproductive potential must use effective birth control - No cystic neoplasms of the pancreas - No islet cell, periampullary or cholangiocarcinoma - No Federal Medical Center inmates PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for this disease Endocrine therapy: - Not specified Radiotherapy: - No prior radiation therapy for this disease - No prior radiation therapy to the abdomen Surgery: - Celiotomy and standardized exploration for resectability required
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RandallPearson, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000065689; MAYO-974301,NCI-G97-1302
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003049
Other Stage 2 Pancreatic Cancer Studies:
1. Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
2. Gemcitabine With or Without Pemetrexed Disodium in Treating Patients With Unresectable Stage II, Stage III, or Stage IV Pancreatic Cancer
3. Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer
4. Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer
5. Gemcitabine and Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
Related Studies:
Other stage 2 pancreatic cancer Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
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