Selective Dose Escalation for Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00139633
• Other study ID #: ETH097-02D
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 29, 2005
• Last updated: August 29, 2005
• Start date: July 2000
• Est. completion date: June 2005

Study information

• Verified date: August 2005
• Source: The Oregon Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• T1–4, N0–1, M0–1a esophageal carcinoma

Exclusion Criteria:

• distant metastases

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• carboplatin, 5FU, Taxol and radiation

Locations

Country	Name	City	State
United States	The Oregon Clinic	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
The Oregon Clinic	Bristol-Myers Squibb, MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival at 4 years
Primary	local control at 4 years