Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophagus Cancer |
Drug: Paclitaxel Drug: Carboplatin Drug: 5-Fluorouracil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer |
- 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
- 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.
| Estimated Enrollment: | 200 |
| Study Start Date: | October 1999 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
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)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | SCRI Oncology Research Consortium, SCRI |
| ClinicalTrials.gov Identifier: | NCT00193141 History of Changes |
| Other Study ID Numbers: | SCRI GI 23 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Fluorouracil Carboplatin Paclitaxel Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013