Clinical trial NCT00069953
Conditions: Esophageal Cancer
Keywords: adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage II esophageal cancer stage III esophageal cancer
Sponsor: Radiation Therapy Oncology Group
Start date: 2003-09-01; Completion date: 2016-12-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
Interventions: intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: cisplatin intervention 4: fluorouracil intervention 5: paclitaxel intervention 6: conventional surgery intervention 7: radiation therapy
Intervention descriptions: intervention 1: 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. intervention 2: During induction therapy, patients receive 6 mg subcutaneously on days 6 and 34. intervention 3: 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. intervention 4: 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. intervention 5: During induction therapy, patients receive 200 mg/m\^2/day by IV over 2 hours on days 1 and 29. intervention 6: Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy. intervention 7: 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.

Protocol documents: