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Sponsors and Collaborators: |
Nordic Society for Gynaecologic Oncology European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005583 |
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: This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk endometrial cancer.
Condition | Intervention | Phase |
---|---|---|
Endometrial Cancer |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma |
Estimated Enrollment: | 400 |
Study Start Date: | January 2000 |
OBJECTIVES:
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.
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial cancer of 1 of the following types:
No spread of disease outside the uterine corpus except to pelvic lymph nodes
No preoperative macroscopic tumor involvement of the cervix
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Belgium | |
Cazk Groeninghe - Campus Maria's Voorzienigheid | |
Kortrijk, Belgium, B-8500 | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
France | |
Centre Henri Becquerel | |
Rouen, France, 76038 | |
Ireland | |
Coombe Women's Hospital | |
Dublin, Ireland, 8 | |
St. James's Hospital | |
Dublin, Ireland, 8 | |
Italy | |
Azienda Ospedaliera Di Parma | |
Parma, Italy, 43100 | |
Fondazione I.R.C.C.S. Policlinico San Matteo | |
Pavia, Italy, 27100 | |
Istituto Nazionale per lo Studio e la Cura dei Tumori | |
Naples, Italy, 80131 | |
Ospedale di Circolo e Fondazione Macchi | |
Varese, Italy, 21100 | |
Netherlands | |
Medisch Spectrum Twente | |
Enschede, Netherlands, 7500 KA | |
Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands, 1091 HA | |
Universitair Medisch Centrum St. Radboud - Nijmegen | |
Nijmegen, Netherlands, NL-6500 HB | |
Norway | |
Norwegian Radium Hospital | |
Oslo, Norway, N-0310 | |
Poland | |
Medical University of Gdansk | |
Gdansk, Poland, 80-211 | |
Portugal | |
Hospitais da Universidade de Coimbra (HUC) | |
Coimbra, Portugal, 3049 | |
South Africa | |
Groote Schuur Hospital | |
Cape Town, South Africa, 7925 | |
Spain | |
Hospital Universitario Central de Asturias | |
Oviedo, Spain, 33006 | |
Hospital Universitario San Carlos | |
Madrid, Spain, 28040 | |
United Kingdom, England | |
Nottingham City Hospital NHS Trust | |
Nottingham, England, United Kingdom, NG5 1PB | |
United Kingdom, Northern Ireland | |
Centre for Cancer Research and Cell Biology at Belfast City Hospital | |
Belfast, Northern Ireland, United Kingdom, BT9 7AB | |
United Kingdom, Scotland | |
Western Infirmary | |
Glasgow, Scotland, United Kingdom, G11 6NT |
Study Chair: | Gunnar B. Kristensen, MD, PhD | Norwegian Radium Hospital |
Investigator: | Carlos F. de Oliveira, MD, PhD | Hospitais da Universidade de Coimbra (HUC) |
Study ID Numbers: | CDR0000067646, NSGO-EC9501, EORTC-55991 |
Study First Received: | May 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005583 History of Changes |
Health Authority: | United States: Federal Government |
stage I endometrial carcinoma stage II endometrial carcinoma endometrial adenocarcinoma endometrial papillary carcinoma endometrial clear cell carcinoma |
Adjuvants, Immunologic Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Endometrial Cancer Epirubicin Doxorubicin Carcinoma |
Genital Diseases, Female Anti-Bacterial Agents Endometrial Neoplasms Adenocarcinoma, Clear Cell Cisplatin Carcinoma, Papillary Uterine Neoplasms Adenocarcinoma |
Antineoplastic Agents Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Antibiotics, Antineoplastic Epirubicin Pharmacologic Actions |
Doxorubicin Genital Diseases, Female Endometrial Neoplasms Neoplasms Neoplasms by Site Therapeutic Uses Uterine Neoplasms |