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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006011 |
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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer.
Condition | Intervention | Phase |
Endometrial Cancer |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: filgrastim Drug: paclitaxel Drug: pegfilgrastim Procedure: adjuvant therapy Procedure: radiation therapy |
Phase III |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Filgrastim Cisplatin Paclitaxel Pegfilgrastim |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma |
Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy field (pelvic vs extended field).
Within 8 weeks after surgery, patients receive tumor volume-directed pelvic radiotherapy with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16 weeks after surgery.
Within 8 weeks of completing radiotherapy, patients are randomized to 1 of 2 chemotherapy treatment arms.
Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 614 patients (307 per treatment arm) will be accrued for this study within 5.2 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced endometrial carcinoma with any histology, including:
Surgical stage III disease, including:
Must have had prior surgery, including hysterectomy and bilateral salpingo-oophorectomy
Paraaortic lymph node sampling allowed
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Show 71 Study Locations |
Gynecologic Oncology Group |
National Cancer Institute (NCI) |
Eastern Cooperative Oncology Group |
Study Chair: | Howard D. Homesley, MD | Gynecologic Oncology Network |
Study Chair: | Higinia R. Cardenes, MD, PhD | Indiana University Melvin and Bren Simon Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068020, GOG-0184, ECOG-G0184, RTOG-EN0130 |
First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006011 |
Health Authority: | United States: Federal Government |
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