Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193141

Enrollment

200

Registered

2005-09-19

Start date

1999-10-31

Completion date

2007-07-31

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Cancer

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)

Interventions

DRUGPaclitaxel

DRUGCarboplatin

DRUG5-Fluorouracil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of full dose radiation therapy versus preoperative radiation therapy plus surgical resection, when used in combination with neo-adjuvant chemotherapy, in the treatment of localized esophageal cancer	—

Secondary

Measure	Time frame
To compare the toxicity of these two treatment approaches in localized esophageal cancer	—
To evaluate the utility of clinical restaging in guiding local therapy (surgical resection vs definitive radiation therapy) following neo-adjuvant treatment	—
To evaluate the toxicity of additional chemotherapy and radiation therapy following completion of neo-adjuvant treatment.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026