Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer

Phase 2

Terminated

• Conditions: Esophageal Cancer
• Interventions: Drug: carboplatin; Drug: fluorouracil; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

• Registration Number: NCT00006472
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy drugs and radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy given before surgery in treating patients who have stage I, stage II, or stage III esophageal cancer.

Detailed Description

OBJECTIVES: I. Determine the total response rate in patients with stage I, II, or III esophageal cancer treated with paclitaxel, carboplatin, and fluorouracil with concurrent radiotherapy followed by surgical resection. II. Determine the overall survival of these patients treated with this regimen. II. Determine the toxicity of this regimen in this patient population.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1 and 22, and fluorouracil IV continuously on days 1-42. Patients undergo radiotherapy concurrently with chemotherapy daily 5 days a week for 5 weeks. Patients then undergo surgical resection within 3-5 weeks following completion of therapy. Patients are followed every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2000-11-06
• Primary Completion: 2001-11-15
• Status Verified: 2002-02
• Study Completion: 2002-09-10
• Study First Submitted QC: 2004-02-25
• Study First Posted: 2004-02-26
• Last Update Submitted: 2020-08-14
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	conventional surgery	Taxol® (Paclitaxel), Carboplatin and 5-Fluorouracil with Simultaneous Radiotherapy Followed by Surgical Resection
Single arm study	radiation therapy	Taxol® (Paclitaxel), Carboplatin and 5-Fluorouracil with Simultaneous Radiotherapy Followed by Surgical Resection
Single arm study	paclitaxel	Taxol® (Paclitaxel), Carboplatin and 5-Fluorouracil with Simultaneous Radiotherapy Followed by Surgical Resection
Single arm study	carboplatin	Taxol® (Paclitaxel), Carboplatin and 5-Fluorouracil with Simultaneous Radiotherapy Followed by Surgical Resection
Single arm study	fluorouracil	Taxol® (Paclitaxel), Carboplatin and 5-Fluorouracil with Simultaneous Radiotherapy Followed by Surgical Resection

Trial Locations

Locations (6)

Union Memorial Hospital; 🇺🇸 Baltimore, Maryland, United States

Harbor Hospital Center; 🇺🇸 Baltimore, Maryland, United States

Franklin Square Hospital Center; 🇺🇸 Baltimore, Maryland, United States

Good Samaritan Hospital of Maryland; 🇺🇸 Baltimore, Maryland, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Washington Cancer Institute; 🇺🇸 Washington, District of Columbia, United States