Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

NCT ID: NCT00193141

Last Updated: 2011-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2007-07-31

Brief Summary

In this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. All patients will receive our previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU, and radiation therapy to 45 Gy. At the completion of neo-adjuvant therapy, patients will be randomized to undergo surgical resection, or to continue radiation to a total dose of 60 Gy, along with one additional course of chemotherapy.

Detailed Description

Upon determination of eligibility, all patients will receive neo-adjuvant therapy with:

Paclitaxel + Carboplatin + 5-Fluorouracil + Radiation

After neo-adjuvant therapy and restaging are completed, patients will be randomized to receive one of two treatments:

• Surgical resection (Arm A)
• Paclitaxel + Carboplatin + Radiation (Arm B)

Conditions

Esophagus Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

5-Fluorouracil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

To be included in this study, you must meet the following criteria:

• Cancer of the esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
• Received no previous treatment for esophageal cancer.
• Measurable or evaluable disease
• Able to perform activities of daily living with minimal assistance
• Adequate bone marrow, liver and kidney function
• Be at least 3 weeks from any major surgical procedures.
• Have an indwelling central venous access catheter.
• Patients must be able to understand the nature consent of the study and give written informed consent.

Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

• Age < 18 years
• History of a prior malignancy within the past 5 years
• History of significant heart disease
• Inoperable on the basis of co-existent medical problems

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

SCRI

Principal Investigators

John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

References

Hainsworth JD, Meluch AA, Gray JR, Spigel DR, Meng C, Bearden JD, Hermann R, Greco FA. Concurrent chemoradiation followed by esophageal resection vs chemoradiation alone for localized esophageal cancer. Community Oncology 4:431-439, 2007.

Reference Type: RESULT

Related Links

http://www.communityoncology.net/journal/articles/0407431.pdf

Community Oncology article

Other Identifiers

SCRI GI 23

Identifier Type: -

Identifier Source: org_study_id