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Home > "G" Clinical Trials Conditions > Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas  Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
For Condition: stage 1 pancreatic cancer,adenocarcinoma of the pancreas
Status: Completed
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy after surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.
Details: OBJECTIVES: - Determine the time to disease progression, local control, and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the absence of disease progression or unacceptable toxicity. Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and with less than 10% weight loss during study receive additional gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses. Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive adenocarcinoma of the pancreas - Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months - No clinical evidence of gross residual disease at time of surgery - No focally positive margins (tumor at the margin) - No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - More than 6 months Hematopoietic: - Granulocyte count greater than 1,500/mm3 - Hemoglobin greater than 10 g/dL - Platelet count greater than 100,000/mm3 Hepatic: - Bilirubin less than 2.0 mg/dL Renal: - Creatinine less than 2.0 mg/dL Other: - Able to maintain adequate oral nutrition - Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study - No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast - Non-metastatic prostate cancer allowed if more than 2 year survival likely - No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent routine growth factors Chemotherapy: - No prior chemotherapy for pancreatic cancer Endocrine therapy: - Not specified Radiotherapy: - No prior abdominal radiotherapy for pancreatic cancer Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArthurBlackstock, Study Chair, Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Additional Information:
Study ID Numbers: CDR0000068452; CCCWFU-57198,NCI-104
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010166
Other Adenocarcinoma Of The Pancreas Studies:
1. Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
2. Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
3. Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer
4. Perifosine in Treating Patients With Advanced Pancreatic Cancer
5. Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
Related Studies:
Other adenocarcinoma of the pancreas Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
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