At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
- ✓Primary (non-recurrent) disease
- ✓Resectable disease, stage greater than T1, N0
- ✓Tumor entirely confined to esophagus/gastroesophageal junction and periesophageal soft tissue, extending no more than 2 cm into stomach
- ✕Multiple primary carcinomas of the esophagus
- ✕Cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus
- ✕Evidence of disseminated cancer (liver metastases, palpable supraclavicular nodes, or celiac adenopathy >2 cm)
- ✕Prior chest or upper abdomen radiotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus
In Brief
A Phase 2 clinical trial evaluating filgrastim, pegfilgrastim, and 5 other interventions for Esophageal Cancer. Completed, enrolled 43 participants across 97 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin use 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. Combining chemotherapy with radiation therapy may kill more tumor cells PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.
Study Details
Timeline
Interventions
During induction therapy, patients ≤ 70 kg will receive 300 μg OR patients \>70 kg will receive 480 μg subcutaneously on days 6-15 and 34-42.
During induction therapy, patients receive 6 mg subcutaneously on days 6 and 34.
During induction therapy, patients receive 15 mg/m\^2/day by IV over 1 hour on days 1-5 and 29-33. During radiotherapy, patients receive 15 mg/m\^2/day by IV over 1 hour beginning on days 57-61.
During induction therapy, patients receive 650 mg/m\^2/day by IV continuously over 96 hours beginning on days 1 and 29. During radiotherapy, patients receive 300 mg/m\^2/day by IV continuously over 96 hours beginning on day 57 for 5 cycles.
During induction therapy, patients receive 200 mg/m\^2/day by IV over 2 hours on days 1 and 29.
Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.
External beam radiotherapy with megavoltage linear accelerators (\> 6 MV) will be used to deliver multiple (\> 2) field techniques. Patients will be treated 5 days/week at 1.8 Gy/day for 28 days for a total dose of 50.4 Gy.