Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer

NCT00002493 | Completed Phase 3 DMC

• 2 other identifiers: GOG-0122CDR0000077572
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 58

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which treatment regimen is more effective for endometrial cancer. PURPOSE: Randomized phase III trial to compare radiation therapy with chemotherapy in treating patients who have advanced endometrial cancer.

Conditions

Endometrial Cancer; Psychosocial Effects of Cancer and Its Treatment

Keywords

stage III endometrial carcinoma; stage IV endometrial carcinoma; endometrial adenocarcinoma; endometrial adenosquamous cell carcinoma; endometrial adenoacanthoma; endometrial papillary serous carcinoma; endometrial clear cell carcinoma; psychosocial effects of cancer and its treatment

Interventions

cisplatin DRUG

doxorubicin hydrochloride DRUG

low-LET photon therapy RADIATION

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Pathological stage III/IV endometrial carcinoma of any histology (including clear cell and serous papillary carcinomas) The following extent of disease eligible: Positive adnexa Tumor invading the serosa Positive pelvic nodes Positive para-aortic nodes Involvement of the bowel mucosa Intra-abdominal metastases Positive pelvic washings Vaginal involvement within the radiotherapy field Hysterectomy and bilateral salpingo-oophorectomy (BSO) required with residual tumor not greater than 2 cm at any site Selective pelvic and para-aortic lymph node sampling optional for patients with stage III/IV disease by other criteria If para-aortic nodes are positive, scalene nodes must be negative on biopsy and chest CT must be negative for intrathoracic disease The following disease conditions exclude: Parenchymal liver metastasis Lung metastasis Positive inguinal nodes Positive scalene nodes Recurrent disease Protocol therapy must begin within 8 weeks after surgery PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Left ventricular ejection fraction normal Other: No past or concomitant malignancy other than nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior progestational agents allowed No other prior endocrine therapy Radiotherapy: No prior pelvic or abdominal radiotherapy Surgery: Hysterectomy and BSO required Pelvic and para-aortic lymph node sampling optional (see Disease Characteristics)

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

Sponsors & Collaborators

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

Study Sites (58)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

CCOP - Greater Phoenix

Phoenix, Arizona, 85006-2726, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Women's Cancer Center

Palo Alto, California, 94304, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

Vincent T. Lombardi Cancer Research Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5265, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, 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

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Cooper Hospital/University Medical Center

Camden, New Jersey, 08103, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, 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

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-9832, 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

Brookview Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Baptist Cancer Institute

Memphis, Tennessee, 38117, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Cancer Center, University of Virginia HSC

Charlottesville, Virginia, 22908, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Related Publications (9)

• Moore KN, Tian C, McMeekin DS, Thigpen JT, Randall ME, Gallion HH. Does the progression-free interval after primary chemotherapy predict survival after salvage chemotherapy in advanced and recurrent endometrial cancer?: a Gynecologic Oncology Group ancillary data analysis. Cancer. 2010 Dec 1;116(23):5407-14. doi: 10.1002/cncr.25480. Epub 2010 Aug 24.

  PMID: 20737572 BACKGROUND

• Diavolitsis V, Boyle J, Singh DK, Small W Jr. The role of adjuvant radiation in endometrial cancer. Oncology (Williston Park). 2009 Apr 15;23(4):342-9.

  PMID: 19476264 BACKGROUND

• Modesitt SC, Tian C, Kryscio R, Thigpen JT, Randall ME, Gallion HH, Fleming GF; Gynecologic Oncology Group. Impact of body mass index on treatment outcomes in endometrial cancer patients receiving doxorubicin and cisplatin: a Gynecologic Oncology Group study. Gynecol Oncol. 2007 Apr;105(1):59-65. doi: 10.1016/j.ygyno.2006.10.045. Epub 2006 Dec 5.

  PMID: 17150247 BACKGROUND

• Modesitt S, Tian C, Kryscio R, et al.: Impact of body mass index (BMI) on treatment outcomes in advanced or recurrent endometrial cancer patients receiving doxorubicin/cisplatin chemotherapy: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-93, 2006.

  BACKGROUND

• Tewari KS, Filiaci VL, Spirtos NM, Mannel RS, Thigpen JT, Cibull ML, Monk BJ, Randall ME. Association of number of positive nodes and cervical stroma invasion with outcome of advanced endometrial cancer treated with chemotherapy or whole abdominal irradiation: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Apr;125(1):87-93. doi: 10.1016/j.ygyno.2011.12.414. Epub 2011 Dec 8.

  PMID: 22155678 RESULT

• Bruner DW, Barsevick A, Tian C, Randall M, Mannel R, Cohn DE, Sorosky J, Spirtos NM. Randomized trial results of quality of life comparing whole abdominal irradiation and combination chemotherapy in advanced endometrial carcinoma: A gynecologic oncology group study. Qual Life Res. 2007 Feb;16(1):89-100. doi: 10.1007/s11136-006-9003-5. Epub 2006 Oct 11.

  PMID: 17033909 RESULT

• Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group Study. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Jan 1;24(1):36-44. doi: 10.1200/JCO.2004.00.7617. Epub 2005 Dec 5.

  PMID: 16330675 RESULT

• Randall ME, Brunetto G, Muss H, et al.: Whole abdominal radiotherapy versus combination doxorubicin-cisplatin chemotherapy in advanced endometrial carcinoma: a randomized phase III trial of the Gynecologic Oncology Group. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-3, 2, 2003.

  RESULT

• Waltkins-Bruner D, Barsevick A, Tian C, et al.: Quality of life trade-off to incremental gain in survival on Gynecologic Oncology Group (GOG) Protocol 122: whole abdominal irradiation (WAI) vs. doxorubicin-platinum (AP) chemotherapy in advanced endometrial cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1803, 449, 2003.

  RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Cisplatin; Doxorubicin

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; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Marcus E. Randall, MD

  Indiana University Melvin and Bren Simon Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 23, 2004
• Study Start: May 1, 1992
• Primary Completion: April 1, 2001
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (58)