Selective Dose Escalation for Esophageal Cancer
This trial is active, not recruiting.
|Treatment||carboplatin, 5fu, taxol and radiation|
|Sponsor||The Oregon Clinic|
|Start date||July 2000|
|End date||June 2005|
|Trial size||25 participants|
|Trial identifier||NCT00139633, ETH097-02D|
This prospective study was designed to assess the outcomes (survival and failure patterns) of therapy for localized esophageal cancer with conventional dose radiation (RT; 50.4 Gy) with concurrent continuous infusion 5-fluorouracil (5-FU) and weekly carboplatin/paclitaxel. Patients with less than complete response (CR) or partial response (PR) received dose escalation of radiation to 59.4 Gy with the same chemotherapy.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
survival at 4 years
local control at 4 years
Male or female participants at least 18 years old.
Inclusion Criteria: - T1–4, N0–1, M0–1a esophageal carcinoma Exclusion Criteria: - distant metastases
|Official title||Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer|
|Description||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.|
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