Endometrial Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONStereotactic body radiotherapy (SBRT)
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
Sponsors
Fundacao Champalimaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Endometrial Cancer adjuvant treatment: Exclusive fractionated radiosurgery 21 Gy/3 fractions (BED10 35,7 Gy) prescribed to 100% isodose at 5 mm from the mucosa surface and 150% isodose to the mucosa surface (BED10 64,675 Gy)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathology proven adenocarcinoma of the endometrium * National Comprehensive Cancer Network (NCCN) intermediate and high risk * Unstaged patients with \< 50% myometrium invasion; * Age ≥ 18; * World health organization - Eastern Cooperative Oncology Group (WHO-ECOG) performance status 0-2 or Karnofsky performance status (KPS) ≥ 70; * Hemoglobin ≥ 8.0 g/dl; white blood cells count (WBC) ≥ 1,500/mm3 ; Platelets ≥ 40,000 cells/mm3 . * Signed informed consent
Exclusion criteria
* Evidence of post-surgical macroscopic residual disease; * Patients with anatomical incompatibility with online tracking device; * Psychiatric conditions; * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; * Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields; * Severe active co-morbidities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetric Feasibility of vaginal cuff SBRT | through study completion, an average of 3 year | 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) |
| Reproducibility of vaginal cuff SBRT | Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time | Anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold |
| Inter/intra fractional target motion | during the 15 minutes of treatment delivery time | 3D deviations recorded in CBCT images and electromagnetic recording |
| Adverse Events | through study completion, an average of 5 years | Treatment related side effects based on CTCAE V3.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local control | through study completion, an average of 5 years | Free from loco-regional relapse |
| Distant Relapse | through study completion, an average of 5 years | Free from distant relapse |
| Quality of life metrics | through study completion, an average of 5 years | change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30 |
Countries
Portugal
Outcome results
None listed