Selective Dose Escalation for Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin, 5FU, Taxol and radiation
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, chemotherapy, radiation
Eligibility Criteria
Inclusion Criteria: T1-4, N0-1, M0-1a esophageal carcinoma Exclusion Criteria: distant metastases
Sites / Locations
- The Oregon Clinic
Outcomes
Primary Outcome Measures
survival at 4 years
local control at 4 years
Secondary Outcome Measures
Full Information
NCT ID
NCT00139633
First Posted
August 29, 2005
Last Updated
August 29, 2005
Sponsor
The Oregon Clinic
Collaborators
Bristol-Myers Squibb, MedImmune LLC
1. Study Identification
Unique Protocol Identification Number
NCT00139633
Brief Title
Selective Dose Escalation for Esophageal Cancer
Official Title
Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Oregon Clinic
Collaborators
Bristol-Myers Squibb, MedImmune LLC
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
esophageal cancer, chemotherapy, radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
carboplatin, 5FU, Taxol and radiation
Primary Outcome Measure Information:
Title
survival at 4 years
Title
local control at 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
T1-4, N0-1, M0-1a esophageal carcinoma
Exclusion Criteria:
distant metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven K Seung, MDPhD
Organizational Affiliation
The Oregon Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Selective Dose Escalation for Esophageal Cancer
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