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Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer Clinical research trials and Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer. Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer  Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
For Condition: stage 2 pancreatic cancer,adenocarcinoma of the pancreas,stage 3 pancreatic cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Randomizedphase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advancedpancreatic cancer.
Details: OBJECTIVES: - Compare the percentage of margin-free resections in patients with locally advanced, potentially resectable adenocarcinoma of the pancreas treated with gemcitabine and radiotherapy vs gemcitabine, fluorouracil, and cisplatin followed by radiotherapy and fluorouracil. - Compare the efficacy of these regimens, as measured by CT scan response, in these patients. - Compare the posttreatment fibrosis in resected specimens of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the duration of objective response in patients treated with these regimens. - Compare the disease-free and overall survival of patients treated with these regimens. - Compare the effect of these regimens and disease recurrence on CA 19-9 values in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to superior mesenteric vein (SMV)/portal vein (PV) occlusion (yes vs no), SMV/PV/superior mesenteric artery/hepatic artery abutment or narrowing (yes vs no), prior exploration (yes vs no), and whether deemed to require preoperative therapy due to other factors (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive gemcitabine IV over 50 minutes once weekly for 6 weeks during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy. Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. - Patients receive gemcitabine IV over 30 minutes on days 1, 5, 29, and 33; cisplatin IV over 60 minutes on days 1-5 and 29-33; and fluorouracil IV continuously on days 1-4 and 29-32. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily on days 6-15 and 34-43 and epoetin alfa SC weekly on weeks 1-9. After completion of chemotherapy, patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive fluorouracil IV continuously daily during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy. Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 80-160 patients (40-80 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the pancreas - No adenosquamous cancers or adenocarcinoma associated with cystic mucinous neoplasms - Locally advanced disease that is potentially resectable, previously explored and considered unresectable, or deemed to require preoperative treatment for other reasons - Primary cancer in the head, body, or tail of pancreas - Measurable disease - No 360 degree encirclement of the superior mesenteric artery, hepatic artery, or celiac axis - No metastases by CT scan and laparoscopy (if prior surgery, only CT scan required) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count greater than 2,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic - Bilirubin less than 2 mg/dL (unless secondary to bile duct blockage by tumor) - Biliary obstruction by tumor requires biliary stent at least 9 French or biliary bypass before therapy Renal - Creatinine less than 1.7 mg/dL OR - Creatinine clearance greater than 60 mL/min Other - No other malignancy within the past 3 years except nonmelanoma skin cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for this disease Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to pancreas Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnHoffman, Study Chair, Fox Chase Cancer Center
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Veterans Affairs Medical Center - Atlanta (Decatur) *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Maria Amarante Ribeiro 404-728-7680
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
Additional Information:
Study ID Numbers: CDR0000258056; ECOG-E1200
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049348
Other Stage 2 Pancreatic Cancer Studies:
1. Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
2. Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed
3. Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas
4. Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
5. Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
Related Studies:
Other stage 2 pancreatic cancer Clinical Trials
Other Illinois Clinical Trials
Other Urbana Clinical Trials
Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
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