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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
The Oregon Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, chemotherapy, radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 29, 2005
Last Updated
August 29, 2005
Sponsor
The Oregon Clinic
Collaborators
Bristol-Myers Squibb, MedImmune LLC
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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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