Home
Search
Study Topics
Glossary
|
|
|
|
|
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 |
Biological: filgrastim Biological: pegfilgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy |
Phase III |
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.
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:
Study Chair: | Howard D. Homesley, MD | Gynecologic Oncology Network |
Study Chair: | Higinia R. Cardenes, MD, PhD | Indiana University Melvin and Bren Simon Cancer Center |
Study ID Numbers: | CDR0000068020, GOG-0184, ECOG-G0184, RTOG-EN0130 |
Study First Received: | July 5, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006011 History of Changes |
Health Authority: | United States: Federal Government |
stage III endometrial carcinoma endometrial adenocarcinoma endometrial adenosquamous cell carcinoma |
endometrial adenoacanthoma endometrial papillary carcinoma endometrial clear cell carcinoma |
Adjuvants, Immunologic Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Endometrial Cancer Antimitotic Agents Doxorubicin Carcinoma Genital Diseases, Female Anti-Bacterial Agents Endometrial Neoplasms |
Adenocarcinoma, Clear Cell Radiation-Sensitizing Agents Cisplatin Paclitaxel Tubulin Modulators Carcinoma, Papillary Uterine Neoplasms Adenocarcinoma Antineoplastic Agents, Phytogenic Carcinoma, Adenosquamous |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Antimitotic Agents Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin |
Genital Diseases, Female Endometrial Neoplasms Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Paclitaxel Therapeutic Uses Tubulin Modulators Uterine Neoplasms Antineoplastic Agents, Phytogenic |