POSE - POs Surgery Endometrial Cancer

Endometrial Cancer Clinical Trial

— POSE  

Official title:

POSE (POs Surgery Endometrial Cancer) - Phase I/II Study to Access SBRT as a Replacement for Brachytherapy in Intermediate and High Risk in Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06394258
• Other study ID #: POSE2
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: October 8, 2021

Study information

• Verified date: April 2024
• Source: Fundacao Champalimaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 8, 2021
• Est. primary completion date: July 18, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Radiation:
• Stereotactic 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

Locations

Country	Name	City	State
Portugal	Champalimaud Foundation	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Fundacao Champalimaud

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	through study completion, an average of 3 year
Primary	Reproducibility of vaginal cuff SBRT	Anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold	Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
Primary	Inter/intra fractional target motion	3D deviations recorded in CBCT images and electromagnetic recording	during the 15 minutes of treatment delivery time
Primary	Adverse Events	Treatment related side effects based on CTCAE V3.0	through study completion, an average of 5 years
Secondary	Quality of life metrics	change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30	through study completion, an average of 5 years
Secondary	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	through study completion, an average of 5 years
Secondary	Quality of life metrics	scoring more than 12 points in Hospital Anxiety and Depression Scale (HADS)	through study completion, an average of 5 years
Secondary	Local control	Free from loco-regional relapse	through study completion, an average of 5 years
Secondary	Distant Relapse	Free from distant relapse	through study completion, an average of 5 years