Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193141
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 3, 2011
Bristol-Myers Squibb
Information provided by:
SCRI Development Innovations, LLC

September 12, 2005
September 19, 2005
May 3, 2011
October 1999
October 2004   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00193141 on Archive Site
  • 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.
Same as current
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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
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.

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)
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Esophagus Cancer
  • Drug: Paclitaxel
  • Drug: Carboplatin
  • Drug: 5-Fluorouracil
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2007
October 2004   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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SCRI Oncology Research Consortium, SCRI
SCRI Development Innovations, LLC
Bristol-Myers Squibb
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP