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Selective Dose Escalation for Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by The Oregon Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Bristol-Myers Squibb
MedImmune LLC
Information provided by:
The Oregon Clinic
ClinicalTrials.gov Identifier:
NCT00139633
First received: August 29, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer

Resource links provided by NLM:

Drug Information available for: Carboplatin
U.S. FDA Resources

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on June 17, 2013