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Selective Dose Escalation for Esophageal Cancer

NCT ID: NCT00139633

Last Updated: 2005-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Esophageal Cancer

Keywords

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esophageal cancer, chemotherapy, radiation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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carboplatin, 5FU, Taxol and radiation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* T1-4, N0-1, M0-1a esophageal carcinoma

Exclusion Criteria

* distant metastases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

MedImmune LLC

INDUSTRY

Sponsor Role collaborator

The Oregon Clinic

OTHER

Sponsor Role lead

Principal Investigators

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Steven K Seung, MDPhD

Role: STUDY_CHAIR

The Oregon Clinic

Locations

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The Oregon Clinic

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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ETH097-02D

Identifier Type: -

Identifier Source: org_study_id