Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Cancer of the Esophagus

Sponsor

Radiation Therapy Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002631

Collaborator

National Cancer Institute (NCI) (NIH), Eastern Cooperative Oncology Group (Other), North Central Cancer Treatment Group (Other)

298

Enrollment

Locations

16.6

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy 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. It is not known whether high-dose radiation therapy is more effective than standard dose radiation therapy in treating cancer of the esophagus.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus high- or standard-dose radiation therapy in treating patients with cancer of the esophagus.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: chemotherapy Drug: cisplatin Drug: fluorouracil Radiation: low-LET electron therapy Radiation: low-LET photon therapy	Phase 3

Detailed Description

OBJECTIVES: I. Compare, using a prospective controlled randomized study design, the survival and failure patterns associated with conventional-dose radiotherapy and fluorouracil/cisplatin (5-FU/CDDP) vs. high-dose radiotherapy and 5-FU/CDDP in patients with esophageal cancer. II. Compare the tolerance and quality of life of patients receiving these therapies.

OUTLINE: Randomized study. Arm I: Radiotherapy plus 2-Drug Combination Chemotherapy/Radiosensitization. Tumor irradiation using megavoltage photons of at least 6 MV (electrons may be used if required to boost supraclavicular fossa dose); plus Cisplatin, CDDP, NSC-119875; Fluorouracil, 5-FU, NSC-19893. High-dose radiotherapy. Arm II: Radiotherapy plus 2-Drug Combination Chemotherapy/Radiosensitization. Tumor irradiation as in Arm I; plus CDDP/5-FU. Conventional-dose radiotherapy.

PROJECTED ACCRUAL: Up to 298 patients will be entered over 4 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

298 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A PHASE III INTERGROUP RANDOMIZED COMPARISON OF COMBINED MODALITY THERAPY FOR CARCINOMA OF THE ESOPHAGUS: HIGH-DOSE VS CONVENTIONAL-DOSE RADIATION THERAPY

Study Start Date :

Jun 1, 1995

Actual Primary Completion Date :

Sep 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Biopsy-proven primary squamous cell or adenocarcinoma of the esophagus Clinical Stage T1-4, Nx, M0 disease required Disease entirely confined to the esophagus and periesophageal soft tissue with no tumor extension within 2 cm proximal to the stomach No biopsy-proven invasion of the tracheal-bronchial tree or tracheal-esophageal (TE) fistula Bronchoscopy of tracheal-bronchial tree required for lesions less than 30 cm from the incisors to exclude TE fistula Negative liver biopsy required if liver CT suggestive of metastatic disease Negative biopsy required for enlarged (1.5 cm or greater) retroperitoneal or celiac nodes seen on CT Negative biopsy of clinically or radiographically positive supraclavicular nodes required with cervical primaries No recurrent disease No multiple carcinomas of the esophagus

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100%

Hematopoietic: WBC at least 4,000 Platelets at least 150,000 Hb at least 10 g/dL Hepatic:

Not specified Renal: Creatinine normal OR Creatinine clearance at least 65 mL/min Nutrition: Recommended oral intake requirements (by mouth or tube feeding): More than 1.5 x Basal Energy Expenditure (BEE) measured by Harris- Benedict equation OR More than 1,000 calories/sqm of body surface area (BSA) Intravenous hyperalimentation (recommended if inadequate oral intake): 1.75-2.25 x BEE OR 1,200-1,600 calories/sqm BSA Upper limits may be waived for hypermetabolic patients Other: No second malignancy within 5 years except: Curable nonmelanomatous skin cancer Cervical cancer in situ No pregnant or nursing women

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent growth factor administration Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest irradiation Surgery: No prior resection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
3	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
4	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
5	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	10309-1016
6	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
7	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
8	CCOP - Duluth	Duluth	Minnesota	United States	55805
9	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
10	CentraCare Clinic	Saint Cloud	Minnesota	United States	56303
11	Quain & Ramstad Clinic, P.C.	Bismarck	North Dakota	United States	58501
12	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
13	Altru Health Systems	Grand Forks	North Dakota	United States	58201
14	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
15	CCOP - Geisinger Clinical and Medical Center	Danville	Pennsylvania	United States	17822-2001
16	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
17	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57105-1080
18	Saskatchewan Cancer Agency	Regina	Saskatchewan	Canada	S4S 6X3