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

NCT ID: NCT00006472

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2002-09-10

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm study

Taxol® (Paclitaxel), Carboplatin and 5-Fluorouracil with Simultaneous Radiotherapy Followed by Surgical Resection

Group Type: OTHER

carboplatin

Intervention Type: DRUG

Carboplatin AUC 6 days 1 and 22

fluorouracil

Intervention Type: DRUG

5FU 225mg/m2 continuous infusion on days 1-42 during radiation

paclitaxel

Intervention Type: DRUG

taxol

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

The initial fields should be treated AP:PA when possible to a dose of 4500 cGy in 180 cGy fractions

Interventions

carboplatin

Carboplatin AUC 6 days 1 and 22

Intervention Type: DRUG

fluorouracil

5FU 225mg/m2 continuous infusion on days 1-42 during radiation

Intervention Type: DRUG

paclitaxel

taxol

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

The initial fields should be treated AP:PA when possible to a dose of 4500 cGy in 180 cGy fractions

Intervention Type: RADIATION

Other Intervention Names

paraplatin; 5FU; 200mg/m2 days 1 and 22

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the upper, middle, or lower third esophagus Stage I, II, or III disease Measurable disease No distant metastases Negative liver biopsy Negative bone scan unless due to benign disease No tracheobronchial involvement No vocal cord paralysis No phrenic nerve involvement No celiac axis lymph node involvement unless due to primary cancer at gastroesophageal junction No evidence of disseminated cancer

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled or severe cardiovascular disease No congestive heart failure No myocardial infarction within the past 6 months No severe or uncontrolled hypertension (systolic greater than 150 mmHg and diastolic greater than 100 mmHg) Pulmonary: FEV1/FVC at least 75% predicted Arterial blood saturation at least 92% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No other serious medical illness that would limit survival to fewer than 2 years No active uncontrolled bacterial, viral, or fungal infection No active uncontrolled duodenal ulcer No psychiatric disorder that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest radiotherapy Surgery: No prior surgical resection of tumor Other: No prior therapy for esophageal cancer

• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Principal Investigators

David J. Perry, MD

Role: STUDY_CHAIR

Medstar Health Research Institute

Locations

Washington Cancer Institute

Washington D.C., District of Columbia, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

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

Countries

United States

Other Identifiers

WHC-99692

Identifier Type: -

Identifier Source: secondary_id

NCI-V00-1633

Identifier Type: -

Identifier Source: secondary_id

CDR0000068295

Identifier Type: -

Identifier Source: org_study_id