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

Endometrial Cancer Clinical Trial

Official title:

WHOLE ABDOMINAL RADIOTHERAPY VERSUS CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY IN ADVANCED ENDOMETRIAL CARCINOMA -- PHASE III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002493
• Other study ID #: GOG-0122
• Secondary ID: CDR0000077572
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: February 12, 2014
• Start date: May 1992

Study information

• Verified date: February 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES: I. Compare overall survival, progression-free interval, and patterns of failure of maximally debulked patients with stage III/IV endometrial carcinoma treated with whole-abdominal irradiation vs. doxorubicin/cisplatin. II. Compare the incidence and type of acute and late adverse events observed with these two treatment regimens. III. Compare changes in fatigue, elimination, and neurologic impairment that impact on quality of life in patients treated with these two regimens. IV. Assess the difference in short-term versus long-term impact on quality of life between the two treatment groups. V. Compare quality-of-life outcomes over time between these two treatment groups.

OUTLINE: Randomized study. Arm I: Radiotherapy. Whole-abdominal irradiation using equipment with photon energies ranging from 6 to 25 MV. Arm II: 2-Drug Combination Chemotherapy. Doxorubicin, DOX, NSC-123127; Cisplatin, CDDP, NSC-119875.

PROJECTED ACCRUAL: It is anticipated that 355 patients will be entered over 7.4 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Drug:
• cisplatin

• doxorubicin hydrochloride

Radiation:
• low-LET photon therapy

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Johns Hopkins Oncology Center	Baltimore	Maryland
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cancer Center, University of Virginia HSC	Charlottesville	Virginia
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	CCOP - Kansas City	Kansas City	Missouri
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	CCOP - Baptist Cancer Institute	Memphis	Tennessee
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Women's Cancer Center	Palo Alto	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Greater Phoenix	Phoenix	Arizona
United States	University of Rochester Cancer Center	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Washington Medical Center	Seattle	Washington
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Stanford University Medical Center	Stanford	California
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Tacoma General Hospital	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Brookview Research, Inc.	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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 g — View Citation

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. Review. — View Citation

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.

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. Epub 2006 Dec 5. — View Citation

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. — View Citation

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 Ame

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 carcin — View Citation

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 irradia — View Citation

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 endometria