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Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer



Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer

For Condition: stage 2 endometrial cancer,endometrial clear cell carcinoma,endometrial papillary carcinoma,stage 1 endometrial cancer
Status: Recruiting
Sponsor(s): Medical Research Council ,
Synopsis: RATIONALE: Lymphadenectomy may remove cancer cells that have spread to nearby lymph nodes. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether conventional surgery is more effective with or without lymphadenectomy and/or radiation therapy in treating endometrial cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of conventional surgery with or without lymphadenectomy and/or radiation therapy in treating patients who have endometrial cancer.
Details: OBJECTIVES: - Compare the effects of conventional surgery alone and conventional surgery plus lymphadenectomy in patients with endometrial cancer preoperatively thought to be confined to the uterine corpus. - Determine the effect of postoperative adjuvant external beam radiotherapy on quality of life and survival of a subset of these patients at high risk of relapse and with no macroscopic disease after surgery. OUTLINE: This is a randomized, multicenter study. Patients are randomized in both the surgery and radiotherapy segments of the study. - Patients are randomized to 1 of 2 surgery arms. - Arm I: Patients undergo conventional surgery (total abdominal hysterectomy and bilateral salpingo-oophorectomy). - Arm II: Patients undergo conventional surgery as in arm I followed by lymphadenectomy with systematic dissection of the iliac and obturator nodes. - Patients at high risk of relapse who have no postoperative macroscopic disease are randomized to 1 of 2 radiotherapy arms. (Patients may enter the radiotherapy randomization after surgery off study.) - Arm I: Patients receive in 20-25 fractions of external beam radiotherapy (total dose of 40-46 Gy) over 4-5 weeks. - Arm II: Patients receive no external beam radiotherapy. NOTE: Some patients receive vault brachytherapy regardless of radiotherapy randomization. Quality of life is assessed before therapy and at 2 and 5 years after therapy. Patients are followed every 3 months for 1 year and then every 6 months for 1 year. PROJECTED ACCRUAL: A minimum of 1400 patients will be accrued for the surgical component of this study and at least 900 patients (including additional patients not participating in the surgical component of this study) will be accrued for the radiotherapy component of this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Surgical randomization: - Histologically confirmed endometrial carcinoma - Disease thought preoperatively to be confined to the uterine corpus Radiotherapy randomization: - Must have disease determined postoperatively to be confined to the uterine corpus, irrespective of pelvic node status - No cervical stroma invasion (stage IIB) - Must be macroscopically free of disease (no positive para-aortic nodes) - Must have high-risk disease defined as one or more of the following: - Grade 3 (poorly differentiated) - Invasion to the outer half of the myometrium (stage IC) - Serous papillary or clear cell type - Stage IIA (endocervical glandular involvement) PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No other prior or concurrent malignancy likely to interfere with protocol treatment or comparisons - Surgical randomization: - Must be fit to undergo lymphadenectomy and external beam radiotherapy - Radiotherapy randomizations: - Must be fit to receive external beam radiotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ClaireAmos,  ,  Medical Research Council

Medical Research Council Clinical Trials Unit *Recruiting*
London,  England,  NW1 2DA
United Kingdom
Recruiting Claire  Amos 44-020-7670-4700 ext. 4795

Royal Marsden NHS Trust - London *Recruiting*
London,  England,  SW3 6JJ
United Kingdom
Recruiting Peter  Blake 44-20-7808-2581

St. Mary's Hospital *Recruiting*
Manchester,  England,  M13 0JH
United Kingdom
Recruiting H.C.  Kitchener 44-161-276-6461


Additional Information:
Study ID Numbers:  CDR0000066869;  MRC-ASTEC,EU-98062
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003749

Other Stage 1 Endometrial Cancer Studies:
1. Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer

2. Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

4. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer

5. Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer

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Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer
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