RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin 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. Combining chemotherapy with radiation therapy may kill more tumor cells PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.
OBJECTIVES: * Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil followed by chemoradiotherapy and possible surgical salvage in patients with resectable locally advanced carcinoma of the esophagus or gastroesophageal junction. * Determine the overall and disease-free survival of patients treated with this regimen. * Determine the treatment-related toxicity of this regimen in these patients. * Determine the tolerance to surgical salvage in patients treated with this regimen. * Determine the morbidity and mortality of surgical salvage in patients treated with this regimen. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and 34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence of unacceptable toxicity. * Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV continuously on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients concurrently undergo external beam radiotherapy on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy. Patients are followed periodically. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
During induction therapy, patients ≤ 70 kg will receive 300 μg OR patients \>70 kg will receive 480 μg subcutaneously on days 6-15 and 34-42.
During induction therapy, patients receive 6 mg subcutaneously on days 6 and 34.
During induction therapy, patients receive 15 mg/m\^2/day by IV over 1 hour on days 1-5 and 29-33. During radiotherapy, patients receive 15 mg/m\^2/day by IV over 1 hour beginning on days 57-61.
During induction therapy, patients receive 650 mg/m\^2/day by IV continuously over 96 hours beginning on days 1 and 29. During radiotherapy, patients receive 300 mg/m\^2/day by IV continuously over 96 hours beginning on day 57 for 5 cycles.
During induction therapy, patients receive 200 mg/m\^2/day by IV over 2 hours on days 1 and 29.
Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.
External beam radiotherapy with megavoltage linear accelerators (\> 6 MV) will be used to deliver multiple (\> 2) field techniques. Patients will be treated 5 days/week at 1.8 Gy/day for 28 days for a total dose of 50.4 Gy.
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Saint Rose Hospital
Hayward, California, United States
Providence Holy Cross Cancer Center
Mission Hills, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Summit Medical Center
Oakland, California, United States
Overall Survival (1-year Rate Reported)
One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).
Time frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.
Frequency of Major (Grade 4) Acute Treatment-related Toxicities
Time frame: From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery).
Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection
Time frame: Analysis occurs with the primary outcome measure.
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