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


Phase 3
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Bruce D. Minsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064043

NCT ID:

NCT00002631

Start Date:

June 1995

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • stage I esophageal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CentraCare ClinicSaint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080