Clinical trialPhase 2Completed
A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- September 2002
- Expected end
- September 2012
- Enrollment
- 50 participants
- Sites
- 1
- Primary outcomes
- Incidence of Severe Toxicities
- Sponsor
- Other
- Results posted
- 2015-05-27
- Last update
- 27 May 2015
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Brief summary public domain (ClinicalTrials.gov)
To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Incidence of Severe Toxicities [1 month after completion of treatment (treatment lasts approximately 19 weeks)]. Number, percentage of participants. Arm 1 (n=48): 20.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Toxicities Associated With Treatment (Grade 1-2) [30 days after completion of treatment (treatment lasts approximately 19 weeks)]. Number, percentage of participants. Mucositis: Arm 1 (n=48): 31. Nausea: Arm 1 (n=48): 48. Vomiting: Arm 1 (n=48): 23. Diarrhea: Arm 1 (n=48): 31. Dehydration: Arm 1 (n=48): 17. Weight loss: Arm 1 (n=48): 27. Fatigue: Arm 1 (n=48): 67. Renal toxicity: Arm 1 (n=48): 13. Hepatotoxicity: Arm 1 (n=48): 69. Infection: Arm 1 (n=48): 13. Neutropenia: Arm 1 (n=48): 46. Anemia: Arm 1 (n=48): 65. Thrombocytopenia: Arm 1 (n=48): 46.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Toxicities Associated With Treatment (Grade 3-4) [30 days after completion of treatment (treatment lasts approximately 19 weeks)]. Number, percentage of participants. Mucositis: Arm 1 (n=48): 2. Nausea: Arm 1 (n=48): 4. Vomiting: Arm 1 (n=48): 4. Diarrhea: Arm 1 (n=48): 15. Dehydration: Arm 1 (n=48): 4. Weight loss: Arm 1 (n=48): 0. Fatigue: Arm 1 (n=48): 8. Renal toxicity: Arm 1 (n=48): 0. Hepatotoxicity: Arm 1 (n=48): 4. Infection: Arm 1 (n=48): 15. Neutropenia: Arm 1 (n=48): 23. Anemia: Arm 1 (n=48): 4. Thrombocytopenia: Arm 1 (n=48): 6.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Free Survival (DFS) - Median [Median follow-up was 24 months (range 3.2-97 months)]. Median, months (95% Confidence Interval). Pancreatic cancer: Arm 1 (n=48): 9.6 (5.8 to 11.6). Biliary/ampullary cancer: Arm 1 (n=48): 12.7 (7.9 to 18.9).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Free Survival (DFS) - Median [Median follow-up was 24 months (range 3.2-97 months)]. Median, months (95% Confidence Interval). Pancreatic cancer: Arm 1 (n=30): 12.8 (5.9 to 17.5). Biliary cancer/ampullary cancer: Arm 1 (n=30): 15.0 (8.1 to 18.9).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) - Median [Median follow-up was 24 months (range 3.2-97 months)]. Median, months (95% Confidence Interval). Pancreatic cancer: Arm 1 (n=48): 17.6 (8.6 to 23.8). Biliary cancer/ampullary cancer: Arm 1 (n=48): 23.8 (11.4 to 47.0).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [1 year]. Number, percentage of participants (95% Confidence Interval). Pancreatic cancer: Arm 1 (n=48): 60.7 (45.0 to 81.8). Biliary/ampullary cancer: Arm 1 (n=48): 75.0 (58.0 to 96.6).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [2 years]. Number, percentage of participants (95% Confidence Interval). Pancreatic cancer: Arm 1 (n=48): 32.1 (18.8 to 55.1). Biliary/ampullary cancer: Arm 1 (n=48): 49.1 (31.2 to 77.3).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) - Median [Median follow-up was 24 months (range 3.2-97 months)]. Median, months (95% Confidence Interval). Pancreatic cancer: Arm 1 (n=30): 24.5 (9.7 to 29.4). Biliary cancer/ampullary cancer: Arm 1 (n=30): 23.8 (12.8 to 70.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [1 year]. Number, percentage of participants (95% Confidence Interval). Pancreatic cancer: Arm 1 (n=30): 78.6 (59.0 to 100.0). Biliary/ampullary cancer: Arm 1 (n=30): 81.2 (64.2 to 100.0).
Papers 1
- Registry-listed results paperA phase II study of adjuvant gemcitabine plus docetaxel followed by concurrent chemoradation in resected pancreaticobil… DOI 10.1111/hpb.12413↗
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.