Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer
18 Years
N/A
Both
Esophageal Cancer
Trial Information
Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer
we prospectively enrolled patients with T1–4, N0–1, M0–1a esophageal carcinoma to receive
paclitaxel 45 mg/m2 IV over 1 hour and carboplatin AUC 2 IV over 30 minutes on days 1, 8,
15, 22, 29 and 36. 5-FU 225mg/m2 was delivered as a continuous infusion on days 1–38. RT
was given 1.8Gy 5 days/wk for 5.5 wks (50.4Gy in 28 fx). After 6–8 weeks, patients
underwent repeat staging with computed tomography (CT) scan, endoscopic ultrasound (EUS),
and biopsy. Patients with a positive biopsy, or less than PR by CT and EUS, received a
boost of 9 Gy with the same concurrent chemotherapy. Patients were followed every 4 months
with CT/EUS first year, every 6 months thereafter.
Inclusion Criteria:
- T1–4, N0–1, M0–1a esophageal carcinoma
Exclusion Criteria:
- distant metastases
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
survival at 4 years
Principal Investigator
Steven K Seung, MDPhD
Investigator Role:
Study Chair
Investigator Affiliation:
The Oregon Clinic
Authority:
United States: Institutional Review Board
Study ID:
ETH097-02D
NCT ID:
NCT00139633
Start Date:
July 2000
Completion Date:
June 2005
Related Keywords:
- Esophageal Cancer
- esophageal cancer, chemotherapy, radiation
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| The Oregon Clinic | Portland, Oregon 97213 |
