Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer

NCT00006027 | Completed Phase 3 DMC

• 3 other identifiers: RTOG-9905CDR0000068040GOG-0194
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 29

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without combination chemotherapy for endometrial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without combination chemotherapy following surgery in treating patients who have stage I or stage II endometrial cancer.

Conditions

Endometrial Cancer

Keywords

stage I endometrial carcinoma; stage II endometrial carcinoma; endometrial adenocarcinoma; endometrial adenosquamous cell carcinoma; endometrial adenoacanthoma; endometrial clear cell carcinoma; endometrial papillary serous carcinoma

Interventions

cisplatin DRUG

paclitaxel DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed uterine confined endometrioid endometrial adenocarcinoma with one of the following: * Grade 2 or 3 carcinoma with more than 50% myometrial invasion (stage IC and IIA) * Grade 2 or 3 carcinoma with stromal invasion of the cervix (stage IIB) * No grade I adenocarcinoma * Less than 50% papillary serous or clear cell histology on pathologic specimen * Prior hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) and bilateral salpingo-oophorectomy with or without additional surgical staging for endometrial cancer no more than 8 weeks prior to study * No known metastatic extrauterine metastases, known gross residual disease, positive peritoneal cytology, or distant metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,800/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT no greater than 3 times normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No cardiac dysrhythmias Other: * No other malignancy within the past 5 years except nonmelanomatous skin cancer * No medical contraindications to study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• Gynecologic Oncology Group: collaborator

Study Sites (29)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1740, United States

Location

Community Hospital of Los Gatos

Los Gatos, California, 95032, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103-1489, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11794-8091, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1065, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425-2233, United States

Location

Brookview Research, Inc.

Nashville, Tennessee, 37203, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Cisplatin; Paclitaxel; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Kathryn M. Greven, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

• Richard R. Barakat, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Primary Completion: June 1, 2004
• Last Updated: October 22, 2020

Record last verified: 2013-08

Locations

US (28); NO (1)