Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients
|Endometrial Cancer||Radiation: IMRT Radiation: Intracavitary vaginal brachytherapy Drug: Paclitaxel Drug: Carboplatin||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients|
- The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy. [ Time Frame: 1 year from the start of radiation therapy. ]
The study will be deemed infeasible if greater than 10% of patients experience one of the following:
- Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her.
- The patient experiences any grade 4 acute toxicity judged to be related to her external radiation treatment.
- Within 1 year of the start of radiation therapy, the patient develops any grade 4 late toxicity judged to be related to her external radiation treatment.
- Within 1 year of the start of radiation therapy, the patient develops any in-field pelvic recurrence.
- Within 1 year of the start of radiation therapy, the patient dies from causes judged to be related to her treatment.
- Evaluate incidence of early toxicities [ Time Frame: 30 days after last day of radiation therapy ]
- Evaluate incidence of late toxicities [ Time Frame: 1 year from the start of radiation therapy ]
- Evaluate local, regional, and distant recurrence rates [ Time Frame: 5 years from start of radiation therapy ]
- Evaluate 5-year disease-free and 5-year overall survival rates [ Time Frame: 5 years from start of radiation therapy ]
|Study Start Date:||April 2006|
|Study Completion Date:||September 2015|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: IMRT with chemotherapy
IMRT (upper third of vagina & para-vaginal tissue and the common, external and internal iliac nodal regions) 160-180 cGy daily fractions for a total dose of 4500-5120 cGy. Once a day treatment four to five days a week for approximately 6 weeks.
Intracavitary vaginal brachytherapy - some patients will be given this and it will be decided by the treating physician.
Carboplatin - AUC 6, IV over 30-60 minutes following completion of paclitaxel, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles
Paclitaxel - 175 mg/m2, 3 hour continuous IV infusion, administered prior to carboplatin, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles
Radiation: Intracavitary vaginal brachytherapy
Other Name: TaxolDrug: Carboplatin
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334321
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Perry W Grigsby, M.D.||Washington University School of Medicine|