Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	RTOG-0246 NCT00069953

Objectives

1. 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.
2. Determine the overall and disease-free survival of patients treated with this regimen.
3. Determine the treatment-related toxicity of this regimen in these patients.
4. Determine the tolerance to surgical salvage in patients treated with this regimen.
5. Determine the morbidity and mortality of surgical salvage in patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,500/mm³
• Platelet count at least 150,000/mm³
• 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

Expected Enrollment

A total of 42 patients will be accrued for this study within 18 months.

Outcomes

Overall survival rate at 1 year
Frequency of major (grade 4) acute toxicities
Frequency of patients with persistent or recurrent disease eligible for surgical salvage resection

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.

Swisher S, Winters K, Komaki R, et al.: A phase II study of a paclitaxel based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-190, S106, 2007.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Stephen Swisher, MD, Protocol chair		Ph: 713-792-8659; 800-392-1611

Registry Information
Official Title		A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus
Trial Start Date		2003-09-05
Registered in ClinicalTrials.gov		NCT00069953
Date Submitted to PDQ		2003-05-16
Information Last Verified		2006-02-15
NCI Grant/Contract Number		CA21661

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