Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer
Summary
This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride, and radiation therapy before surgery works in treating patients with pancreatic cancer that has not spread to other places in the body and can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Fluorouracil, irinotecan hydrochloride, and gemcitabine hydrochloride may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and gemcitabine hydrochloride with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Timeline
- Start
- 2012-01-27
- Primary completion
- 2021-11-01
- Completion
- 2021-11-01
Outcome
Missed primary endpoint
Stopped (Enrollment): “Study was terminated due to slower than anticipated accrual”
paper The bias corrected R0 rate was 55.6% (90% CI: 33.3, 68.3; P value = .16) PMID 36221952 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Irinotecan | Small molecule | — | Intravenous |
| Subject | Leucovorin | Small molecule | — | Intravenous |
| Subject | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |