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Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

Primary Purpose

Esophagus Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
5-Fluorouracil
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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 Outcome Measures

    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.

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    May 2, 2011
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193141
    Brief Title
    Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
    Official Title
    Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1999 (undefined)
    Primary Completion Date
    October 2004 (Actual)
    Study Completion Date
    July 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Bristol-Myers Squibb

    4. Oversight

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophagus Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Type
    Drug
    Intervention Name(s)
    5-Fluorouracil
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    To compare the toxicity of these two treatment approaches in localized esophageal cancer
    Title
    To evaluate the utility of clinical restaging in guiding local therapy (surgical resection vs definitive radiation therapy) following neo-adjuvant treatment
    Title
    To evaluate the toxicity of additional chemotherapy and radiation therapy following completion of neo-adjuvant treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John D. Hainsworth, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    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.
    Results Reference
    result

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    Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

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