drugset / Trial / NCT00057876
Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
Phase 3
Completed
74 enrolled
Eastern Cooperative Oncology Group
National Cancer Institute (NCI) · collabRadiation Therapy Oncology Group · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy work in 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. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer. PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.
Timeline
- Start
- 2003-08-29
- Primary completion
- 2009-05
- Completion
- 2009-05
Publications
- Results Loehrer PJ, Powell ME, Cardenes HR, et al.: A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201. [Abstract] J Clin Oncol 26 (Suppl 15): A-4506, 2008.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |