At a glance
ClinicalIndex Comparison Record- ✓Adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
- ✓Must be a surgical candidate
- ✓No previous treatment for esophageal cancer
- ✓Measurable or evaluable disease
- ✕Tumor location in the proximal esophagus
- ✕Metastatic disease or locally advanced cancer
- ✕Moderate to severe peripheral neuropathy
- ✕Serious pre-existing medical illnesses
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial of Preoperative Oxaliplatin, Docetaxel, and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction
In Brief
A Phase 2 clinical trial evaluating Oxaliplatin, Docetaxel, and 2 other interventions for Esophagus Cancer. Completed, enrolled 59 participants across 7 sites.
Detailed Summary
In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.
Study Details
Timeline
Interventions
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.
In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).