Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Esophagus Cancer

Treatments

Drug: 5-Fluorouracil

Drug: Paclitaxel

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193141

SCRI GI 23

Details and patient eligibility

About

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.

Full 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)

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.