Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Comprehensive Cancer Center | Birmingham | Alabama | United States | 35294 |
| 2 | CCOP - Greater Phoenix | Phoenix | Arizona | United States | 85006-2726 |
| 3 | USC/Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033-0800 |
| 4 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
| 5 | Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 6 | Women's Cancer Center | Palo Alto | California | United States | 94304 |
| 7 | Stanford University Medical Center | Stanford | California | United States | 94305-5408 |
| 8 | University of Colorado Cancer Center | Denver | Colorado | United States | 80262 |
| 9 | Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington | District of Columbia | United States | 20007 |
| 10 | Walter Reed Army Medical Center | Washington | District of Columbia | United States | 20307-5000 |
| 11 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
| 12 | Emory University Hospital - Atlanta | Atlanta | Georgia | United States | 30322 |
| 13 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342-1701 |
| 14 | MBCCOP - Hawaii | Honolulu | Hawaii | United States | 96813 |
| 15 | Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | United States | 60612 |
| 16 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637 |
| 17 | Indiana University Cancer Center | Indianapolis | Indiana | United States | 46202-5265 |
| 18 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 19 | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | United States | 40536-0084 |
| 20 | Johns Hopkins Oncology Center | Baltimore | Maryland | United States | 21287 |
| 21 | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | United States | 01655 |
| 22 | CCOP - Ann Arbor Regional | Ann Arbor | Michigan | United States | 48106 |
| 23 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 24 | University of Minnesota Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 25 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 26 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 27 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 28 | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68131 |
| 29 | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 30 | Cooper Hospital/University Medical Center | Camden | New Jersey | United States | 08103 |
| 31 | Cancer Center of Albany Medical Center | Albany | New York | United States | 12208 |
| 32 | State University of New York Health Science Center at Brooklyn | Brooklyn | New York | United States | 11203 |
| 33 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
| 34 | University of Rochester Cancer Center | Rochester | New York | United States | 14642 |
| 35 | State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | United States | 11790-9832 |
| 36 | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | United States | 27599-7295 |
| 37 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
| 38 | Brookview Research, Inc. | Winston-Salem | North Carolina | United States | 27103 |
| 39 | Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157-1082 |
| 40 | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | United States | 45219 |
| 41 | Ireland Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
| 42 | Cleveland Clinic Cancer Center | Cleveland | Ohio | United States | 44195 |
| 43 | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | United States | 43210 |
| 44 | University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | United States | 73190 |
| 45 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 46 | Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 47 | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
| 48 | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | United States | 19107 |
| 49 | Pennsylvania Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 50 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 51 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425-0721 |
| 52 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
| 53 | CCOP - Baptist Cancer Institute | Memphis | Tennessee | United States | 38117 |
| 54 | Simmons Cancer Center - Dallas | Dallas | Texas | United States | 75235-9154 |
| 55 | University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 56 | Cancer Center, University of Virginia HSC | Charlottesville | Virginia | United States | 22908 |
| 57 | University of Washington Medical Center | Seattle | Washington | United States | 98195-6043 |
| 58 | Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
Sponsors and Collaborators
- Gynecologic Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Marcus E. Randall, MD, Indiana University Melvin and Bren Simon Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- GOG-0122
- CDR0000077572