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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized 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. It is not yet known whether intensity-modulated radiation therapy is more effective than external-beam radiation therapy in treating patients with early-stage endometrial cancer.
- To compare the incidence of grade 2 or higher acute genitourinary and gastrointestinal toxicity in patients with early-stage endometrial cancer treated with adjuvant pelvic radiotherapy comprising either intensity-modulated radiotherapy or 2-dimensional virtual-simulation planning.
- To compare the incidence of late genitourinary and gastrointestinal toxicity in these patients.
- To determine the feasibility of implementing pelvic nodal irradiation in gynecological cancer.
- To establish an image-guided pathway for gynecological cancer radiotherapy incorporating set-up errors and optimal margins for set-up uncertainty and investigation of effects of bladder filling and rectal preparation protocols on the planning target volume.
- To determine the rate of loco-regional control in these patients.
- To evaluate the quality of life of these patients.
- To determine the rate of disease-free survival of these patients
- To determine the overall survival of these patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients undergo external-beam pelvic radiotherapy delivered using a 2-dimensional virtual-simulation planned technique followed by vaginal vault brachytherapy.
- Arm II (experimental): Patients undergo external-beam pelvic radiotherapy delivered using intensity-modulated radiotherapy followed by vaginal vault brachytherapy.
Patients complete quality of life questionnaires (EORTC QLQ C30 and EORTC QLQ Cervical Cancer Specific Module CX 24) at baseline, at the end of treatment, at 6 and 12 months, once a year for up to year 5, and then twice a year thereafter for up to year 10.
After completion of study treatment, patients are followed every 3 months for year 1, every 6 month for 1 year, and then once a year for up to 10 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
questionnaire administration, adjuvant therapy, assessment of therapy complications, quality-of-life assessment, brachytherapy, external beam radiation therapy, intensity-modulated radiation therapy, radiation therapy treatment planning/simulation
Saint Luke's Hospital
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:00:39-0400
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Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
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