Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
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.
Procedure: conventional surgery
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus|
- Overall survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year. ] [ Designated as safety issue: No ]
- 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). ] [ Designated as safety issue: Yes ]
- Frequency of patients with persistent or recurrent disease eligible for surgical salvage resection [ Time Frame: Analysis occurs with the primary outcome measure. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|Experimental: Induction chemotherapy-chemoradiation-salvage surgery||Biological: filgrastim Biological: pegfilgrastim Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy|
- 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.