Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00334321|
Recruitment Status : Completed
First Posted : June 7, 2006
Last Update Posted : October 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Radiation: IMRT Radiation: Intracavitary vaginal brachytherapy Drug: Paclitaxel Drug: Carboplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||September 2015|
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: Taxol
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|