Selective Dose Escalation for Esophageal Cancer - Full Text View

Sponsors and Collaborators:	The Oregon Clinic Bristol-Myers Squibb MedImmune LLC
Information provided by:	The Oregon Clinic
ClinicalTrials.gov Identifier:	NCT00139633

Purpose

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.

Condition	Intervention	Phase
Esophageal Cancer	Drug: carboplatin, 5FU, Taxol and radiation	Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Carboplatin Paclitaxel Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer

Further study details as provided by The Oregon Clinic:

Primary Outcome Measures:

survival at 4 years
local control at 4 years

Estimated Enrollment:	25
Study Start Date:	July 2000
Estimated Study Completion Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

distant metastases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139633

Locations

United States, Oregon
The Oregon Clinic
Portland, Oregon, United States, 97213

Sponsors and Collaborators

The Oregon Clinic

Bristol-Myers Squibb

MedImmune LLC

Investigators

Study Chair:

Steven K Seung, MDPhD

The Oregon Clinic

More Information

Study ID Numbers:	ETH097-02D
Study First Received:	August 29, 2005
Last Updated:	August 29, 2005
ClinicalTrials.gov Identifier:	NCT00139633
Health Authority:	United States: Institutional Review Board

Keywords provided by The Oregon Clinic:

esophageal cancer, chemotherapy, radiation

Study placed in the following topic categories:

Digestive System Neoplasms
Digestive System Diseases
Esophageal disorder
Paclitaxel
Gastrointestinal Diseases
Fluorouracil

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Carboplatin
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009