At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
- ✓Disease limited to esophagus and regional lymph nodes (celiac nodes acceptable for distal esophagus tumors)
- ✓Disease must be encompassable in a single radiation field
- ✓Age 18-75 years
- ✕Prior treatment for esophageal cancer
- ✕Prior thoracic or upper abdominal radiation
- ✕Active infection or serious intercurrent medical conditions
- ✕Pregnant or lactating females
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pre-Operative Chemoradiation Followed by Post-Operative Tetrathiomolybdate (TM) in Patients With Loco-Regional Esophageal Carcinoma (UMCC 2001-007)
In Brief
A Phase 2 clinical trial evaluating Tetrathiomolybdate (TM), Radiation, and 1 other intervention for Esophageal Carcinoma. Completed, enrolled 69 participants across 1 site.
Detailed Summary
Surgery has been the standard of care for esophageal cancer for many years, with limited success. At present, several studies are underway nationwide which utilize chemotherapy combined with radiation therapy prior to the usual surgical regimen. Although this treatment offers some possibility for improvement of patients with esophageal cancer, there remains a significant need for development of new drugs that can substantially impact survival Investigators at the University of Michigan have been evaluating inhibitors of tumor blood vessel growth (angiogenesis). Specifically, they are evaluating the role of copper in angiogenesis. Copper has been shown to be both a requirement and a potent stimulus for angiogenesis. Previous studies have shown Tetrathiomolybdate (TM) to rapidly lower copper levels in the blood. The physicians at the University of Michigan are studying whether the addition of TM to the chemoradiation and surgery may increase survival for patients with esophageal cancer.
Study Details
Timeline
Interventions
Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.