This phase I/II feasibility study of hypo-fractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to the vaginal cuff in intermedium and high risk endometrial cancer. The primary endpoints are SBRT feasibility and dosimetrical reproducibility to HDR brachytherapy, inter/intra-fractional target motion assessment and toxicity rates. Secondary endpoints are quality of life measures, local control, disease free survival and overall survival.
This phase I/II feasibility study of hypo-fractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to the vaginal cuff aims to reproduce adjuvant High Dose Rate (HDR) brachytherapy dose distributions in patients operated for intermediate and high risk endometrial carcinoma. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time on-line tracking. Eligible patients will receive three SBRT sessions to a prescription dose of 7 Gy to the vaginal cuff (with 4 to 7 days interval). SBRT will start within 4 to 8 weeks post-hysterectomy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 3 months (+/- 6 weeks), at 6 (+/- 6 weeks) and every 6 months (+/- 6 weeks) thereafter for a total of 2 years. The duration of accrual in the study will be up to 3 years. Toxicity and outcome will be compared to published data on the standard modality of care (HDR brachytherapy). Patients' quality of life measures will be collected with validated questionnaires at the baseline and during follow up. Recurrence rates and survival data will be reported.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Stereotactic body radiotherapy to the vaginal cuff with the aim to reproduce adjuvant high dose rate (HDR) brachytherapy dose distribution by means of external beam radiotherapy in patients operated for intermediate risk endometrial carcinoma
Champalimaud Foundation
Lisbon, Portugal
Dosimetric Feasibility of vaginal cuff SBRT
Fulfillment of protocol dosimetrical endpoints and constraints; physician assessment of complications (CTCAE V3.0) at specific time points during follow up (2 weeks, 3 and 6 months, then every 6 months until the end of the 3rd year, then annually until the end of the 5th year)
Time frame: through study completion, an average of 3 year
Reproducibility of vaginal cuff SBRT
Anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold
Time frame: Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
Inter/intra fractional target motion
3D deviations recorded in CBCT images and electromagnetic recording
Time frame: during the 15 minutes of treatment delivery time
Adverse Events
Treatment related side effects based on CTCAE V3.0
Time frame: through study completion, an average of 5 years
Quality of life metrics
change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30
Time frame: through study completion, an average of 5 years
Quality of life metrics
change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire quality of life questionnaire N24
Time frame: through study completion, an average of 5 years
Quality of life metrics
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scoring more than 12 points in Hospital Anxiety and Depression Scale (HADS)
Time frame: through study completion, an average of 5 years
Local control
Free from loco-regional relapse
Time frame: through study completion, an average of 5 years
Distant Relapse
Free from distant relapse
Time frame: through study completion, an average of 5 years