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Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer Clinical research trials and Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer  Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer
Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer
For Condition: stage 1 endometrial cancer,endometrial papillary carcinoma,endometrial adenocarcinoma,endometrial adenosquamous cell carcinoma,endometrial clear cell carcinoma
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known whether receiving radiation therapy after surgery is more effective than receiving no further therapy after surgery for endometrial cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of radiation therapy with that of no further therapy following surgery in treating patients who have stage I endometrial cancer.
Details: OBJECTIVES: - Compare the overall survival in patients with intermediate-risk, stage I endometrial cancer treated with pelvic radiotherapy vs observation after laparoscopically-assisted vaginal hysterectomy or total abdominal hysterectomy and bilateral salpingo-oophorectomy. - Compare the time to locoregional recurrence (i.e., in the vaginal mucosa or elsewhere in the central pelvic area or lateral pelvic walls) in patients treated with these regimens. - Compare the duration of ultimate pelvic control and event-free survival in patients treated with these regimens. - Compare the toxic effects of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. - Compare sexual health issues in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, tumor grade (1 vs 2 vs 3), surgical staging (yes vs no), and sexual health assessment (yes vs no). Patients undergo laparoscopic-assisted vaginal hysterectomy or total abdominal hysterectomy and bilateral salpingo-oophorectomy. After surgery, patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo observation alone. - Arm II: Beginning within 12 weeks (preferably within 6-8 weeks) after surgery, patients undergo radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Protocol-defined brachytherapy is allowed. Quality of life is assessed at baseline; at 16-18 weeks after surgery (arm I) or 5 and 9 weeks after initiating radiotherapy (arm II); and then at 6, 12, 18, 24, 36, 48, and 60 months. Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven adenocarcinoma or adenosquamous cell carcinoma of the endometrium - Intermediate-risk of recurrence after laparoscopically-assisted vaginal hysterectomy (with or without laparoscopic staging) or total abdominal hysterectomy and bilateral salpingo-oophorectomy - Postoperative pathologic stage IA/IB (grade 3) or stage IC (grade1-3) - Patients with more than 50% myometrial invasion (grade 1 or 2) or less than 50% myometrial invasion (grade 3) but with positive peritoneal cytology also eligible - No pathologically involved lymph nodes if staging procedure performed - Stage I papillary serous or clear cell endometrial cancer allowed PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - ECOG 0-3 Life expectancy: - At least 3 years Hematopoietic: - WBC at least 2,000/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 10 g/dL Hepatic: - Not specified Renal: - Creatinine less than 2 times upper limit of normal - No serious renal disease that would preclude radiotherapy Cardiovascular: - No serious cardiovascular disease that would preclude radiotherapy Other: - No history of inflammatory bowel disease such as ulcerative colitis - No other malignancy within past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, colon cancer, or thyroid cancer - No psychiatric or addictive disorder that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No prior anticancer hormonal therapy - No concurrent progestogens Radiotherapy: - No prior pelvic irradiation - No prior or other concurrent vaginal intracavitary radiotherapy Surgery: - See Disease Characteristics Other: - No prior anticancer therapy - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HimuLukka, Study Chair, Margaret and Charles Juravinski Cancer Centre
Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay, Ontario, P7B 6V4
Canada
Recruiting Sunil P. Gulavita 807-684-7200
Humber River Regional Hospital - Weston *Recruiting*
Weston, Ontario, M9N 1N8
Canada
Recruiting Jonathan Wilson 416-243-4308
Centre Hospitalier de l'Universite de Montreal *Recruiting*
Montreal, Quebec, H2L-4M1
Canada
Recruiting Pierre Drouin 514-890-8000 ext. 27244
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Robert Pearcey 403-432-8517
Cancer Care Ontario - Windsor Regional Cancer Centre *Recruiting*
Windsor, Ontario, N8W 2X3
Canada
Recruiting Kenneth Schneider 519-253-3191, ext. 58566
Newfoundland Cancer Treatment and Research Foundation *Recruiting*
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Recruiting Brent Tompkins 709-777-6480
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Mark Carey 519-685-8273
Royal Hospital for Women *Recruiting*
Saskatoon, Saskatchewan, S7N 0XO
Canada
Recruiting Michael Quinn 306-655-1576
St. Mary's - Duluth Clinic Cancer Center *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting James Krook 218-786-8364
Centre Hospitalier Universitaire de Quebec *Recruiting*
Quebec City, Quebec, G1R 2J6
Canada
Recruiting Marie Plante 418-691-5392
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Himu Lukka 905-387-9495 ext. 64702
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Peter Lim 614-877-6000 ext. 2665
Hopital Charles Lemoyne *Recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Recruiting Kenneth Chan 450-466-5000, ext. 2465
Saskatoon Cancer Centre *Recruiting*
Saskatoon, Saskatchewan, S7N 4H4
Canada
Recruiting Mohamed Mohamed 306-655-2708
Saint John Regional Hospital *Recruiting*
Saint John, New Brunswick, E2L 4L2
Canada
Recruiting Shanmugham Kumar 506-648-6884
CHUS-Hopital Fleurimont *Recruiting*
Fleurimont, Quebec, J1H 5N4
Canada
Recruiting Paul Bessette 819-346-1110 ext. 13056
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Peter Craighead 403-944-1701
Doctor Leon Richard Oncology Centre *Recruiting*
Moncton, New Brunswick, E1C 8X3
Canada
Recruiting Santo Filice 506-862-4030
Northeastern Ontario Regional Cancer Centre - Sudbury *Recruiting*
Sudbury, Ontario, P3E 5J1
Canada
Recruiting Julie Bowen 705-522-6237 ext. 2144
McGill University *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting Luis Souhami 514-934-8040 ext. 43163
Nova Scotia Cancer Centre *Recruiting*
Halifax, Nova Scotia, B3H 1V7
Canada
Recruiting Robert Grimshaw 902-473-4029
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting Wendy Shelley 613-544-2631, ext. 4173
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Anthony Fyles 416-946-0522
Additional Information:
Study ID Numbers: CDR0000064915; CAN-NCIC-EN5,NCI-V96-0945
Study Start Date:
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002807
Other Endometrial Papillary Carcinoma Studies:
1. Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
2. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer
3. Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer
4. Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Related Studies:
Other endometrial papillary carcinoma Clinical Trials
Other Quebec Clinical Trials
Other Fleurimont Clinical Trials
Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer
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