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

NCT ID: NCT00002631

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophageal Cancer

Keywords

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stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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chemotherapy

Intervention Type DRUG

cisplatin

Intervention Type DRUG

fluorouracil

Intervention Type DRUG

low-LET electron therapy

Intervention Type RADIATION

low-LET photon therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role collaborator

North Central Cancer Treatment Group

NETWORK

Sponsor Role collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce D. Minsky, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Thomas M. Pisansky, MD

Role: STUDY_CHAIR

Mayo Clinic

James A. Martenson, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

Site Status

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Site Status

Siouxland Hematology-Oncology

Sioux City, Iowa, United States

Site Status

CCOP - Wichita

Wichita, Kansas, United States

Site Status

CCOP - Duluth

Duluth, Minnesota, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

CentraCare Clinic

Saint Cloud, Minnesota, United States

Site Status

Quain & Ramstad Clinic, P.C.

Bismarck, North Dakota, United States

Site Status

CCOP - Merit Care Hospital

Fargo, North Dakota, United States

Site Status

Altru Health Systems

Grand Forks, North Dakota, United States

Site Status

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, United States

Site Status

CCOP - Geisinger Clinical and Medical Center

Danville, Pennsylvania, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, United States

Site Status

Saskatchewan Cancer Agency

Regina, Saskatchewan, Canada

Site Status

Countries

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United States Canada

References

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Thomas CR Jr, Berkey BA, Minsky BD, Gaspar LE, Herskovic A, Rich TA, Gunderson LL. Recursive partitioning analysis of pretreatment variables of 416 patients with locoregional esophageal cancer treated with definitive concomitant chemoradiotherapy on Intergroup and Radiation Therapy Oncology Group trials. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1405-10. doi: 10.1016/j.ijrobp.2003.09.022.

Reference Type BACKGROUND
PMID: 15050316 (View on PubMed)

Smalley SR, Gunderson L, Tepper J, Martenson JA Jr, Minsky B, Willett C, Rich T. Gastric surgical adjuvant radiotherapy consensus report: rationale and treatment implementation. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):283-93. doi: 10.1016/s0360-3016(01)02646-3.

Reference Type BACKGROUND
PMID: 11872272 (View on PubMed)

Kachnic LA, Winter K, Wasserman T, Kelsen D, Ginsberg R, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Willett CG, Minsky BD. Longitudinal Quality-of-Life Analysis of RTOG 94-05 (Int 0123):A Phase III Trial of Definitive Chemoradiotherapy for Esophageal Cancer. Gastrointest Cancer Res. 2011 Mar;4(2):45-52.

Reference Type RESULT
PMID: 21673875 (View on PubMed)

Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167.

Reference Type RESULT
PMID: 11870157 (View on PubMed)

Kachnic LA, Scott C, Ginsberg R, et al.: One year follow-up reveals no difference in quality of life between high dose and conventional dose radiation: a quality of life assessment of RTOG 94-05. [Abstract] Int J Radiat Oncol Biol Phys 51 (3 suppl 1): A-172, 97, 2001.

Reference Type RESULT

Minsky BD, Berkey B, Kelsen DK, et al.: Preliminary results of Intergroup INT 0123 randomized trial of combined modality therapy (CMT) for esophagel cancer: standard vs high dose radiation therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A927, 2000.

Reference Type RESULT

Other Identifiers

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CDR0000064043

Identifier Type: -

Identifier Source: secondary_id

E-R9405

Identifier Type: -

Identifier Source: secondary_id

NCCTG-914051

Identifier Type: -

Identifier Source: secondary_id

INT-0123

Identifier Type: -

Identifier Source: secondary_id

RTOG-9405

Identifier Type: -

Identifier Source: org_study_id