Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before and after surgery may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer.

Further Study Information

OBJECTIVES:

• Compare the pathologic complete response rate in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with radiotherapy with pre- and post-operative cisplatin plus paclitaxel versus cisplatin plus irinotecan.

• Compare the survival outcome in patients treated with these regimens.

• Compare the toxicity of these regimens in these patients.

• Compare the tolerability of these adjuvant chemotherapy regimens after neoadjuvant chemoradiotherapy in these patients.

• Compare time to progression or recurrence in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs. 1) and stage of disease (T2-3, N0, M0 vs. T1-3, N0-1, M0 or M1A). Patients are randomized to 1 of 2 treatment arms.

• Arm A: Patients receive neoadjuvant radiotherapy once daily, 5 days a week, for 5 weeks beginning on day 1 concurrently with neoadjuvant chemotherapy comprising cisplatin IV (Intravenous) over 2-3 hours followed by irinotecan IV over 30-60 minutes once daily on days 1, 8, 22, and 29. Four to six weeks after completion of neoadjuvant chemoradiotherapy, patients undergo surgical resection. A minimum of 4 weeks after resection, patients receive adjuvant chemotherapy comprising cisplatin and irinotecan as above on days 1 and 8. Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses.

• Arm B: Patients receive neoadjuvant radiotherapy as in arm A concurrently with neoadjuvant chemotherapy comprising paclitaxel IV (Intravenous) over 1 hour followed by cisplatin IV over 2-3 hours once daily on days 1, 8, 15, 22, and 29. Patients then undergo surgical resection as in arm A. A minimum of 4 weeks after resection, patients receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours followed by cisplatin as above on day 1. Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

ACCRUAL: A total of 97 patients (50 on Arm A and 47 on Arm B) were accrued for this study.

Eligibility Criteria

Inclusion Criteria:

• Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or gastroesophageal junction

• Stage T2-3, N0, M0 OR

• Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis)

• Tumor must be considered surgically resectable (T1-3, but not T4)

• Age>=18 years

• ECOG Performance status 0-1

• Adequate hematopoietic, hepatic, renal functions defined by the following within 4 weeks prior to randomization:

• Granulocyte count at least 1,000/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

• Prior curatively treated malignancy allowed if currently disease-free and survival prognosis is more than 5 years

• Fertile patients must use effective contraception

• Endoscopy with biopsy and dilation allowed

Exclusion Criteria:

• Tumor extends more than 2 cm into the cardia

• Pregnant or nursing

• Other concurrent illness that would preclude study therapy or surgical resection

• Concurrent filgrastim (G-CSF) during study radiotherapy

• Prior chemotherapy

• Prior radiotherapy

• Prior surgery

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Larry Kleinberg

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00033657
Information obtained from ClinicalTrials.gov on December 15, 2011

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