Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Camptothecin; Cisplatin; Irinotecan; Paclitaxel

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