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Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer Clinical research trials and Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer. Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer  Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
For Condition: endometrial adenocarcinoma,endometrial papillary carcinoma,stage 1 endometrial cancer,endometrial clear cell carcinoma,stage 2 endometrial cancer
Status: Recruiting
Sponsor(s): Nordic Society for Gynaecologic Oncology , EORTC Gynecological Cancer Cooperative Group
Synopsis: 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 whether radiation therapy with chemotherapy is more effective than radiation therapy alone in treating high-risk endometrial cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have high-risk endometrial cancer.
Details: OBJECTIVES: - Compare relapse-free survival of patients with high-risk endometrial carcinoma treated in the adjuvant setting with either radiotherapy alone or radiotherapy and chemotherapy given sequentially. - Compare overall survival of this patient population treated with these 2 adjuvant regimens. - Evaluate the addition of chemotherapy to standard adjuvant radiotherapy, in terms of toxicity, in these patients. - Study whether the pattern of relapse in these patients is influenced by the addition of chemotherapy to adjuvant radiotherapy. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to center and histologic type (serous papillary and clear cell vs all other types). Patients are randomized to 1 of 2 treatment arms. All patients undergo hysterectomy with bilateral salpingooophorectomy and extirpation of macroscopic suspicious lymph nodes. - Arm I: Within 7 weeks after surgery, patients begin radiotherapy. - Arm II: Patients receive radiotherapy followed by or preceded by chemotherapy*. Patients receive cisplatin IV over 60 minutes and doxorubicin or epirubicin IV over 10-20 minutes on day 1. Treament repeats every 21 days for 4 courses. NOTE: *If radiotherapy is preceded by chemotherapy, radiotherapy begins within 4 weeks after chemotherapy. Patients are followed at 3 and 6 months and then every 6 months for 5 years. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed endometrial cancer of 1 of the following types: - Clear cell carcinoma - Serous papillary carcinoma - Undifferentiated (anaplastic) carcinoma - Poorly differentiated (FIGO grade 3) adenocarcinoma with infiltration to more than half the myometrial thickness - No small cell carcinoma with neuroendocrine differentiation - Primary in FIGO surgical stage I or occult stage II - No spread of disease outside the uterine corpus except to pelvic lymph nodes - No spread of disease to para-aortic lymph nodes - Positive peritoneal washings allowed - No preoperative macroscopic tumor involvement of the cervix - Microscopic tumor involvement of the cervix on histopathological evaluation of the operative uterine specimen allowed PATIENT CHARACTERISTICS: Age: - Any age Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - Adequate bone marrow function - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Adequate hepatic function Renal: - Adequate renal function - Creatinine no greater than 1.4 mg/dL Pulmonary: - Adequate pulmonary function Other: - Not pregnant or nursing - Fit to receive combination chemotherapy - No other malignancy except basal cell or squamous cell skin cancer - No uncontrolled or potentially active site of infection (e.g., fistula or abscesses) - No other concurrent condition that would produce a substantial increase in risk for complications from radiotherapy - No other concurrent condition that would interfere with adequate follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - No prior preoperative irradiation Surgery: - No prior extensive abdominal surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GunnarKristensen, Study Chair, Norwegian Radium Hospital
Groote Schuur Hospital *Recruiting*
Cape Town, , 7925
South Africa
Recruiting Contact Person 27-21-404-4265
Hospitais da Universidade de Coimbra (HUC) *Recruiting*
Coimbra, , 3049
Portugal
Recruiting Contact Person 351-403-939
Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese, , 21100
Italy
Recruiting Contact Person 39-278-111
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-541-3111
Hospital Central de Asturias *Recruiting*
Oviedo, , 33006
Spain
Recruiting Contact Person 351-40-3939
Belfast City Hospital Trust *Recruiting*
Belfast, Northern Ireland, BT9 7AB
United Kingdom
Recruiting Contact Person 44-90-32-9241
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-59-99-111
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-821-3000
Medisch Spectrum Twente *Recruiting*
ENSCHEDE, , 7500 KA
Netherlands
Recruiting Contact Person 31-487-2000
Cazk Groeninghe - Campus St-Niklaas *Recruiting*
Kortrijk, , B-8500
Belgium
Recruiting Contact Person 32-56-242-590
Hospital Universitario San Carlos *Recruiting*
Madrid, , 28040
Spain
Recruiting Contact Person 34-330-3000
Azienda Ospedaliera Di Parma *Recruiting*
Parma, , 43100
Italy
Recruiting Contact Peron 39-290-787
I.R.C.C.S. Policlinico San Matteo *Recruiting*
Pavia, , 27100
Italy
Recruiting Contact Person 39-502-640
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-33-2211
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF4 7XL
United Kingdom
Recruiting Contact Person 44-206-15-888
Medical University of Gdansk *Recruiting*
Gdansk, , 80-211
Poland
Recruiting Contact Person 48-349-2222
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Contact Person 47-934-000
Western Infirmary *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Contact Person 44-330-4006
Centre Henri Becquerel *Recruiting*
Rouen, , 76038
France
Recruiting Contact Person 33-232-082-222
Additional Information:
Study ID Numbers: CDR0000067646; NSGO-EC9501,EORTC-55991
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005583
Other Endometrial Clear Cell Carcinoma Studies:
1. Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
3. Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
4. Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer
5. Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
Related Studies:
Other endometrial clear cell carcinoma Clinical Trials
Other Clinical Trials
Other Cape Town Clinical Trials
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
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