Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI); NRG Oncology
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Fluorouracil; Lenograstim; Paclitaxel

Criteria

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