Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Summary
This randomized phase II trial studies how well docetaxel, oxaliplatin, capecitabine, fluorouracil, and radiation therapy works compared with fluorouracil when given together with oxaliplatin and radiation therapy in treating patients with cancer of the esophagus or gastroesophageal junction that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as docetaxel, oxaliplatin, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Timeline
- Start
- 2010-01
- Primary completion
- 2013-12
- Completion
- 2018-03
Outcome
Missed primary endpoint
paper The pathCR rate was 28.6% (8/28) in A versus 40.7% (11/27) in B (P = .34). PMID 33934058 ↗
paper Adding induction chemotherapy prior to trimodality therapy did not improve the primary endpoint, pathCR. PMID 33934058 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | Oral |
| Subject | Docetaxel | Small molecule | — | Intravenous |
| Subject | Oxaliplatin | Small molecule | — | — |
| Subject | fluorouracil | Small molecule | — | Intravenous |