SBRTPURE-cohortNCT07779109
Pelvic Ultra-Hypofractionated Adjuvant Radiotherapy for Endometrial Cancer (PURE-cohort)
A study testing Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy in people with SBRT and Radiation Therapy, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
Trial summary
The PURE trial is a prospective multicenter phase II study evaluating the safety and feasibility of ultra-hypofractionated adjuvant pelvic radiotherapy in patients with high-intermediate-risk and high-risk endometrial cancer following surgery. Read more about this study
- Who is it for?
- Ages 18 to 110 years, women only
- Conditions the study is for
- SBRT, Radiation Therapy, Endometrial Cancer
- What is being tested?
- Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2026to 30 Mar 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 110 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 18 years.
- Histologically confirmed diagnosis of endometrial cancer post hysterectomy: endometrial adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma.
- Patients candidates for adjuvant pelvic (Cht)EBRT treatment (+/- vaginal cuff brachytherapy), categorized by Intermediate-high risk and high risk primary endometrial cancer based on recent ESGO/ESTRO/ESMO Guidelines (2025).
- Patient is willing and able to give informed consent to participate in this clinical trial.
- Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol
- Possibility of fiducial marker placement on vaginal vault.
- Dosimetric feasibility based on OAR constraint and targets objective
Who cannot join
- Prior pelvic or abdominal radiation therapy delivered.
- Inflamatory bowel disease of other contraindication to pelvic radiotherapy.
- Previous abdominal or pelvic complicated surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reyes Ibañez Carreras, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Unidad Clínica Multihospitalaria de Oncología Radioterápica de Aragón (UCMORA)
Zaragoza, Zaragoza, 50009
Marta Gimeno Morales, MD, PhD, +34 976 765500 ext. 142550, mgimenom@salud.argon.es
About this study
Official title: Pelvic Ultra-Hypofractionated Adjuvant Radiotherapy for High-Intermediate and High-Risk Endometrial Cancer: A Prospective Multicenter Phase II Safety Cohort Study
The PURE trial is a prospective multicenter phase II study evaluating the safety and feasibility of ultra-hypofractionated adjuvant pelvic radiotherapy in patients with high-intermediate-risk and high-risk endometrial cancer following surgery. The study investigates a treatment regimen consisting of 27.5 Gy delivered in five fractions using modern image-guided IMRT/VMAT techniques. The primary objective is to assess acute gastrointestinal and genitourinary toxicity according to CTCAE version 5.0.
Read the detailed description
PURE is a prospective multicenter phase II safety study designed to evaluate ultra-hypofractionated adjuvant pelvic radiotherapy in patients with high-intermediate-risk and high-risk endometrial cancer. Eligible patients will receive 27.5 Gy in five fractions delivered over approximately two weeks using image-guided IMRT/VMAT. The study aims to determine whether this regimen achieves acceptable toxicity while preserving treatment efficacy and quality of life. Secondary endpoints include late toxicity, treatment compliance, patient-reported outcomes, locoregional control, disease-free survival, and overall survival. The study employs a Simon optimal two-stage design and plans to enroll 46 evaluable patients.
- Conditions
- SBRT, Radiation Therapy, Endometrial Cancer, Endometrial Cancer Stage III, High-risk Endometrial Cancer
- Being tested
- Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy
- Keywords
- Endometrial cancer, Ultrahypofractionated Radiation Therapy, Postoperative pelvic radiation therapy, Postoperative pelvic sbrt, high-risk endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapyRadiation
Classically, the dose prescribed for adjuvant treatment of endometrial cancer were 45-50Gy in conventional fractionation 1.8Gy/fx, in a total 25-28fx. The shedule proposed on this prospective cohort of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| PURE cohort | Experimental | Patients candidates for adjuvant pelvic (Cht)EBRT treatment (+/- vaginal cuff brachytherapy), categorized by Intermediate-high risk and high risk primary endometrial cancer based on recent ESGO/ESTRO/ESMO Guidelines (2025). Receives: Radiation: Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute GI and GU toxicity
The proportion of participants experiencing acute GI and GU toxicity will be reported, grade by CTCAE (G0-G5). Acute toxicity will be defined during treatment, at 1 and 3 months after the end of treatment.
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (7)
Late GI and GU toxicity
The proportion of participants experiencing late GI and GU toxicity will be reported, grade by CTCAE (G0-G5). Late toxicity will be defined at 6 and 12 months after the end of treatment.
Measured: From enrollment to the end of treatment at 12 months
Evaluate patient-reported quality-of-life EORTC QLQ-C30
Patient reported quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ) C30 (EORTC QLQ-C30) for both the acute and late phases, during treatment, at 1, 3, 6 and 12 months after treatment.
The EORTC QLQ-C30 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much.
A higher score indicates worse quality of life.
Measured: From enrollment to the end of treatment at 12 months
Evaluate patient-reported quality-of-life EORTC QLQ-EN24
Patient reported quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Endometrial Cancer Module (EORTC QLQ-EN24) for both the acute and late phases, during treatment, at 1, 3, 6 and 12 months after treatment. The EORTC QLQ-EN24 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. A higher score indicates worse quality of life.
Measured: From enrollment to the end of treatment at 12 months
Local control
Evaluating absence of vaginal cuff recurrence during follows-up. Local control will be estimated using Kaplan-Meier analysis at 5 years.
Measured: From enrollment to the end of treatment at 5 years
Regional control
Evaluating absence of pelvic recurrence during follows-up. Local control will be estimated using Kaplan-Meier analysis at 5 years.
Measured: From enrollment to the end of treatment at 5 years
Distant control
Evaluating absence of distant recurrence during follows-up. Local control will be estimated using Kaplan-Meier analysis at 5 years.
Measured: From enrollment to the end of treatment at 5 years
Disease free survival
Evaluating patient survival free from any disease progression (local, regional, or distant) or death from any cause. Progression-free survival will be estimated using Kaplan-Meier analysis at 5 years.
Measured: From enrollment to the end of treatment at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start30 Mar 2026
- Primary completion30 Mar 2030 (estimated)
- Study completion30 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SBRTStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARTA GIMENO MORALES, Instituto de Investigación Sanitaria Aragón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779109
- Sponsor's protocol ID
- PI26/093
- Acronym
- PURE-cohort
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 25 Aug 2026
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Ultra-Hypofractionated Adjuvant Radiotherapy for High-Intermediate and High-Risk Endometrial Cancer: A Prospective Multicenter Phase II Safety Cohort Study
- ClinicalTrials.gov ID
- NCT07779109
- Acronym / sponsor ID
- PURE-cohort / PI26/093
- Conditions
- SBRT, Radiation Therapy, Endometrial Cancer, Endometrial Cancer Stage III, High-risk Endometrial Cancer
- Keywords
- Endometrial cancer, Ultrahypofractionated Radiation Therapy, Postoperative pelvic radiation therapy, Postoperative pelvic sbrt, high-risk endometrial cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Mar 2030 (estimated)
- Study completion
- 30 Mar 2035 (estimated)
- First posted
- 21 Aug 2026 (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.
The PURE trial is a prospective multicenter phase II study evaluating the safety and feasibility of ultra-hypofractionated adjuvant pelvic radiotherapy in patients with high-intermediate-risk and high-risk endometrial cancer following surgery. The study investigates a treatment regimen consisting of 27.5 Gy delivered in five fractions using modern image-guided IMRT/VMAT techniques. The primary objective is to assess acute gastrointestinal and genitourinary toxicity according to CTCAE version 5.0.
Detailed description
PURE is a prospective multicenter phase II safety study designed to evaluate ultra-hypofractionated adjuvant pelvic radiotherapy in patients with high-intermediate-risk and high-risk endometrial cancer. Eligible patients will receive 27.5 Gy in five fractions delivered over approximately two weeks using image-guided IMRT/VMAT. The study aims to determine whether this regimen achieves acceptable toxicity while preserving treatment efficacy and quality of life. Secondary endpoints include late toxicity, treatment compliance, patient-reported outcomes, locoregional control, disease-free survival, and overall survival. The study employs a Simon optimal two-stage design and plans to enroll 46 evaluable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PURE cohort | Experimental | Radiation: Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapyPatients candidates for adjuvant pelvic (Cht)EBRT treatment (+/- vaginal cuff brachytherapy), categorized by Intermediate-high risk and high risk primary endometrial cancer based on recent ESGO/ESTRO/ESMO Guidelines (2025). |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged > 18 years.
- Histologically confirmed diagnosis of endometrial cancer post hysterectomy: endometrial adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma.
- Patients candidates for adjuvant pelvic (Cht)EBRT treatment (+/- vaginal cuff brachytherapy), categorized by Intermediate-high risk and high risk primary endometrial cancer based on recent ESGO/ESTRO/ESMO Guidelines (2025).
- Patient is willing and able to give informed consent to participate in this clinical trial.
- Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol
Key exclusion criteria (3 listed)
- Prior pelvic or abdominal radiation therapy delivered.
- Inflamatory bowel disease of other contraindication to pelvic radiotherapy.
- Previous abdominal or pelvic complicated surgery.
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 |
|---|---|---|
| Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapyClassically, the dose prescribed for adjuvant treatment of endometrial cancer were 45-50Gy in conventional fractionation 1.8Gy/fx, in a total 25-28fx. The shedule proposed on this prospective cohort of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy. | Radiation | PURE cohort |
Primary outcome
Acute GI and GU toxicity
Time frame: From enrollment to the end of treatment at 3 months
The proportion of participants experiencing acute GI and GU toxicity will be reported, grade by CTCAE (G0-G5). Acute toxicity will be defined during treatment, at 1 and 3 months after the end of treatment.
7 secondary outcomes
Late GI and GU toxicity
Time frame: From enrollment to the end of treatment at 12 months
Evaluate patient-reported quality-of-life EORTC QLQ-C30
Time frame: From enrollment to the end of treatment at 12 months
Evaluate patient-reported quality-of-life EORTC QLQ-EN24
Time frame: From enrollment to the end of treatment at 12 months
Local control
Time frame: From enrollment to the end of treatment at 5 years
Regional control
Time frame: From enrollment to the end of treatment at 5 years
Distant control
Time frame: From enrollment to the end of treatment at 5 years
Disease free survival
Time frame: From enrollment to the end of treatment at 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- 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.
Reyes Ibañez Carreras, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy in people with SBRT and Radiation Therapy, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
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 3 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Gimeno Morales, MD, PhD (+34 976 76 55 00, ucmorapure@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute GI and GU toxicity (time frame: From enrollment to the end of treatment at 3 months). 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 25 Aug 2026.