Clinical trialPhase 2Completed
Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer
- Outcome
- Finished, no results posted
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 1 December 2000
- Expected end
- 3 October 2003
- Enrollment
- 26 participants
- Sites
- 1
- Sponsor
- Other
- Results posted
- No
- Last update
- 9 September 2021
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
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Source text
Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.
Papers 1
- Registry-listed results paperAdjuvant gemcitabine and concurrent radiation for patients with resected pancreatic cancer: a phase II study. DOI 10.1038/sj.bjc.6603270↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.