Expired Study
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Winston-Salem, North Carolina 27157


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00010166


Primary Contact:

Study Chair
Arthur William Blackstock, MD
Wake Forest University Health Sciences


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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