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

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ClinicalTrials.gov Identifier: NCT00002493
Recruitment Status : Completed
First Posted : August 23, 2004
Last Update Posted : February 14, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

November 1, 1999
August 23, 2004
February 14, 2014
May 1992
April 2001   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002493 on ClinicalTrials.gov Archive Site
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Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer
WHOLE ABDOMINAL RADIOTHERAPY VERSUS CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY IN ADVANCED ENDOMETRIAL CARCINOMA -- PHASE III

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.

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.

Interventional
Phase 3
Primary Purpose: Treatment
  • Endometrial Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Drug: cisplatin
  • Drug: doxorubicin hydrochloride
  • Radiation: low-LET photon therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2001   (Final data collection date for primary outcome measure)

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)

Sexes Eligible for Study: Female
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002493
GOG-0122
CDR0000077572
Yes
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Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Marcus E. Randall, MD Indiana University Melvin and Bren Simon Cancer Center
Gynecologic Oncology Group
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP