Endometrial CancerPOSENCT06394258
POSE - POs Surgery Endometrial Cancer
A study testing Stereotactic body radiotherapy (SBRT) in people with Endometrial Cancer, run by Fundacao Champalimaud at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Stereotactic body radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 18 Jun 2018to 8 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- Stereotactic body radiotherapy (SBRT)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapy (SBRT)Radiation
Also called Stereotactic ablative body radiotherapy (SABR)
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
| Study group | Role | What they receive |
|---|---|---|
| SBRT to the vaginal cuff | Experimental | SBRT to the vaginal cuff Receives: Radiation: Stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: during the 15 minutes of treatment delivery time
Adverse Events
Treatment related side effects based on CTCAE V3.0
Measured: through study completion, an average of 5 years
Secondary outcomes (5)
Quality of life metrics
change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30
Measured: 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
Measured: through study completion, an average of 5 years
Quality of life metrics
scoring more than 12 points in Hospital Anxiety and Depression Scale (HADS)
Measured: through study completion, an average of 5 years
Local control
Free from loco-regional relapse
Measured: through study completion, an average of 5 years
Distant Relapse
Free from distant relapse
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start18 Jun 2018
- Primary completion18 Jul 2020
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacao Champalimaud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inês Antunes, Fundacao Champalimaud
- Investigators
- Carlo Greco, Study director, Radiotherapy Director Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394258
- Sponsor's protocol ID
- POSE2
- Acronym
- POSE
- Status last verified
- Apr 2024
- First submitted
- 10 Jan 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06394258
- Acronym / sponsor ID
- POSE / POSE2
- Conditions
- Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundacao ChampalimaudUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 18 Jul 2020 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| SBRT to the vaginal cuff | Experimental | Radiation: Stereotactic body radiotherapy (SBRT)SBRT to the vaginal cuff |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapy (SBRT)Also: Stereotactic ablative body radiotherapy (SABR)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 | Radiation | SBRT to the vaginal cuff |
Primary outcome
Dosimetric Feasibility of vaginal cuff SBRT
Time frame: 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
Time frame: 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
Time frame: during the 15 minutes of treatment delivery time
3D deviations recorded in CBCT images and electromagnetic recording
Adverse Events
Time frame: through study completion, an average of 5 years
Treatment related side effects based on CTCAE V3.0
5 secondary outcomes
Quality of life metrics
Time frame: through study completion, an average of 5 years
Quality of life metrics
Time frame: through study completion, an average of 5 years
Quality of life metrics
Time frame: through study completion, an average of 5 years
Local control
Time frame: through study completion, an average of 5 years
Distant Relapse
Time frame: through study completion, an average of 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Greco study director
Radiotherapy Director Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiotherapy (SBRT) in people with Endometrial Cancer, run by Fundacao Champalimaud at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetric Feasibility of vaginal cuff SBRT (time frame: through study completion, an average of 3 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.