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Selective Dose Escalation for Esophageal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by The Oregon Clinic.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139633
First Posted: August 31, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bristol-Myers Squibb
MedImmune LLC
Information provided by:
The Oregon Clinic
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • distant metastases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00139633     History of Changes
Other Study ID Numbers: ETH097-02D
First Submitted: August 29, 2005
First Posted: August 31, 2005
Last Update Posted: December 9, 2005
Last Verified: August 2005

Keywords provided by The Oregon Clinic:
esophageal cancer, chemotherapy, radiation

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Carboplatin
Antineoplastic Agents