Overview

This trial is active, not recruiting.

Condition esophageal cancer
Treatments filgrastim, pegfilgrastim, cisplatin, fluorouracil, paclitaxel, conventional surgery, radiation therapy
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date September 2003
End date January 2011
Trial size 43 participants
Trial identifier NCT00069953, CDR0000306455, RTOG-0246

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
filgrastim
pegfilgrastim
cisplatin
fluorouracil
paclitaxel
conventional surgery
radiation therapy

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction - Primary (non-recurrent) disease - Amenable to resection - Stage greater than T1, N0 by endoscopic ultrasound - Must be entirely confined to the esophagus or gastroesophageal junction and periesophageal soft tissue - Tumor may not extend more than 2 cm into the stomach - No multiple primary carcinomas of the esophagus - No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus - No evidence of disseminated cancer - Suggestion of liver metastases by positron emission tomography must be proven negative by biopsy or other imaging studies - Palpable supraclavicular nodes must be negative for cancer by biopsy - Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion - No celiac adenopathy greater than 2 cm PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 150,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Not specified Renal - Creatinine no greater than 1.5 mg/dL AND/OR - Creatinine clearance at least 65 mL/min - Calcium no greater than 11 mg/dL Cardiovascular - No uncontrolled heart disease - No uncontrolled hypertension Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to comprehend study requirements and considered likely to comply with study parameters - No other malignancy within the past 5 years except curable nonmelanoma skin cancer or carcinoma in situ of the cervix - No uncontrolled diabetes - No hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 5 years since prior systemic chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior chest or upper abdomen radiotherapy Surgery - No prior esophageal or gastric surgery Other - No concurrent photodynamic therapy - No other concurrent investigational agents for esophageal carcinoma

Additional Information

Official title A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.