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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00331760 |
RATIONALE: Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.
Condition | Intervention | Phase |
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Cervical Cancer Endometrial Cancer |
Drug: cisplatin Procedure: intensity-modulated radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma |
Estimated Enrollment: | 92 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer).
All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Endometrial cancer meeting 1 of the following criteria:
Stage IIIC with all of the following:
Cervical cancer meeting 1 of the following criteria:
Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:
Disease qualified by Sedlis criteria must have 2 of the following risk factors:
Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) in the past 7 weeks
PATIENT CHARACTERISTICS:
Patients must not exceed the weight and size limits of the treatment table or CT scanner
No severe, active, concurrent illness, defined as any of the following:
PRIOR CONCURRENT THERAPY:
Study Chair: | Anuja Jhingran, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000472905, RTOG-0418 |
Study First Received: | May 30, 2006 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00331760 |
Health Authority: | United States: Federal Government |
stage I endometrial carcinoma stage II endometrial carcinoma stage III endometrial carcinoma endometrial adenoacanthoma endometrial adenocarcinoma endometrial adenosquamous cell carcinoma |
stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma |
Squamous cell carcinoma Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Carcinoma Genital Diseases, Female Epidermoid carcinoma Endometrial Neoplasms |
Cisplatin Carcinoma, squamous cell Uterine Neoplasms Endometrial cancer Carcinoma, Squamous Cell Adenocarcinoma Carcinoma, Adenosquamous |
Neoplasms Neoplasms by Site |