Endometrial CancerPostOP HYPOCxENCT07595224
Postoperative Hypofractionated Whole Pelvic Radiotherapy in Cervical and Endometrial Cancer
A study testing Hypofractionated Radiotherapy and Conventional Radiotherapy in people with Endometrial Cancer and Cervix Cancer, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
This study aims to evaluate a shorter course of postoperative pelvic radiotherapy in patients with cervical and endometrial cancer. The standard radiotherapy schedule usually requires many treatment sessions over several weeks, which can be burdensome for patients and may affect their ability to complete treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometrial Cancer, Cervix Cancer
- What is being tested?
- Hypofractionated Radiotherapy and Conventional Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 11 Mar 2026to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven carcinoma of the uterine cervix; and carcinoma and carcinosarcoma of uterine corpus
- Hysterectomy (total abdominal hysterectomy, vaginal hysterectomy, total laparoscopic hysterectomy or radical hysterectomy) for cancer of the cervix or endometrium within 49 days prior to registration. Hence inadvertent surgery will be allowed for inclusion.
- Indicated for adjuvant EBRT from multidisciplinary team discussion.
- Non-metastatic stage according to FIGO 2018 for Cervical cancer and FIGO 2023 for Endometrial cancer and TNM guidelines from appropriate diagnostic workup 4.1 History/physical examination within 45 days prior to registration 4.2 CT/MRI/PET-CT of abdomen/pelvis demonstrating the absence of distant metastasis, performed pre- or post-surgery within 90 days prior to registration 4.3 Chest x-ray or chest CT (or a PET/CT) performed within 90 days prior to registration
- Age ≥18 years old with informed consent
Who cannot join
- Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
- Small cell neuroendocrine cancer, melanoma, uterine sarcoma, and other rare cancers in the cervix and uterus
- Metastatic disease beyond intervertebral disc L2/3 level
- Previous pelvic or abdominal radiotherapy
- Combination of preoperative chemotherapy or radiotherapy with surgery
- Contra-indications to EBRT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok, Bangkok
Tissana Prasartseree, MD, 66625246101, tissana.p@gmail.com
About this study
Official title: PostOPerative HYPOfractionated Whole Pelvic Radiotherapy in Cervical (Cx) and Endometrial Cancer (PostOP HYPOCxE Trial) : A Phase II Non-inferiority Randomized Controlled Trial
This study aims to evaluate a shorter course of postoperative pelvic radiotherapy in patients with cervical and endometrial cancer. The standard radiotherapy schedule usually requires many treatment sessions over several weeks, which can be burdensome for patients and may affect their ability to complete treatment.
This study will compare a shorter radiotherapy schedule (hypofractionated radiotherapy) with the standard schedule. Both treatments deliver a similar total radiation dose, but the shorter schedule reduces the number of hospital visits and overall treatment time.
Participants will be randomly assigned to receive either the shorter or standard radiotherapy after surgery. The study will evaluate side effects, treatment effectiveness, and quality of life. The goal is to determine whether the shorter treatment is as safe and effective as the standard approach.
Read the detailed description
Cervical cancer remains a major health problem, particularly in low- and middle-income countries. Standard postoperative pelvic radiotherapy requires multiple treatment sessions over several weeks, which may limit patient access, increase treatment burden, and prolong overall treatment time. Prolonged treatment duration has been associated with reduced tumor control, and frequent hospital visits may also increase risks for patients, especially during infectious disease outbreaks.
Hypofractionated radiotherapy delivers a higher dose per fraction while maintaining a similar total radiation dose, allowing for a shorter overall treatment course. This approach may improve treatment convenience, reduce healthcare resource utilization, and potentially enhance treatment outcomes without increasing toxicity. However, there is currently limited high-level evidence supporting its use in the postoperative setting for cervical and endometrial cancer.
This study is a phase II randomized controlled trial designed to evaluate the safety and efficacy of postoperative hypofractionated whole pelvic radiotherapy compared with conventional radiotherapy in patients with cervical and endometrial cancer. Participants will be randomly assigned to receive either hypofractionated or standard radiotherapy following surgery.
The study will assess treatment-related toxicity, tumor response, survival outcomes, and quality of life. The results of this study may help establish whether a shorter radiotherapy schedule can be safely implemented as an alternative to standard treatment.
- Conditions
- Endometrial Cancer, Cervix Cancer
- Being tested
- Hypofractionated Radiotherapy, Conventional Radiotherapy
- Keywords
- Cervical Cancer, Endometrial Cancer, Hypofractionated Radiotherapy, Whole Pelvic Radiotherapy, Postoperative Radiotherapy
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated RadiotherapyRadiation
Postoperative hypofractionated whole pelvic radiotherapy delivered with a higher dose per fraction and a reduced number of treatment sessions compared to conventional radiotherapy, while maintaining a similar total radiation dose.
Conventional RadiotherapyRadiation
Standard postoperative whole pelvic radiotherapy delivered using conventional fractionation with a lower dose per fraction over a greater number of treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| CVRT | Active comparator | Participants receive standard postoperative whole pelvic radiotherapy. Receives: Radiation: Conventional Radiotherapy |
| HYPO | Experimental | Participants receive postoperative hypofractionated whole pelvic radiotherapy. Receives: Radiation: Hypofractionated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Treatment-Related Toxicity
The incidence of acute treatment-related toxicity during radiotherapy and at 1- and 3-month follow-up, assessed using CTCAE version 5.0.
Measured: During treatment and up to 3 months after completion of radiotherapy
Incidence of Late Treatment-Related Toxicity
The incidence of late (chronic) treatment-related toxicity assessed at 6 and 12 months, and at 3 and 5 years after treatment, using CTCAE version 5.0.
Measured: From 6 months up to 5 years after completion of radiotherapy
Secondary outcomes (6)
Tumor Response Rate
Tumor response rate following external beam radiotherapy, assessed during the post-treatment period and at 3-, 6-, and 12-month follow-up.
Measured: Up to 12 months after completion of radiotherapy
Quality of Life Assessed by EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Patient-reported quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) during treatment and at 1-, 3-, 6-, and 12-month, and 3- and 5-year follow-up. The EQ-5D-5L descriptive system evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression across 5 levels of severity. The EQ Visual Analog Scale (EQ-VAS) ranges from 0 to 100, with higher scores indicating better perceived health status.
Measured: From baseline up to 5 years after completion of radiotherapy
Local and Nodal Recurrence-Free Survival
Time from treatment completion to local or nodal disease recurrence.
Measured: Up to 5 years after completion of radiotherapy
Distant Metastasis-Free Survival
Time from treatment completion to distant metastasis
Measured: Up to 5 years after completion of radiotherapy
Overall Survival
Time from completion of radiotherapy to death from any cause.
Measured: Up to 5 years after completion of radiotherapy.
Incremental Cost-effectiveness Ratio per Quality-adjusted Life Year Between Hypofractionated and Conventional Radiotherapy
Cost and utility data will be used to evaluate cost-effectiveness by calculating the incremental cost-effectiveness ratio (ICER) between hypofractionated and conventional radiotherapy. Uncertainty analyses will be performed using one-way sensitivity analysis, probabilistic sensitivity analysis, and threshold analysis.
Measured: During treatment and follow-up up to 5 years after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start11 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wiwatchai Sittiwong, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595224
- Sponsor's protocol ID
- Si 739/2567(IRB4)
- Acronym
- PostOP HYPOCxE
- Status last verified
- May 2026
- First submitted
- 16 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PostOPerative HYPOfractionated Whole Pelvic Radiotherapy in Cervical (Cx) and Endometrial Cancer (PostOP HYPOCxE Trial) : A Phase II Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07595224
- Acronym / sponsor ID
- PostOP HYPOCxE / Si 739/2567(IRB4)
- Conditions
- Endometrial Cancer, Cervix Cancer
- Keywords
- Cervical Cancer, Endometrial Cancer, Hypofractionated Radiotherapy, Whole Pelvic Radiotherapy, Postoperative Radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 May 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.
This study aims to evaluate a shorter course of postoperative pelvic radiotherapy in patients with cervical and endometrial cancer. The standard radiotherapy schedule usually requires many treatment sessions over several weeks, which can be burdensome for patients and may affect their ability to complete treatment.
This study will compare a shorter radiotherapy schedule (hypofractionated radiotherapy) with the standard schedule. Both treatments deliver a similar total radiation dose, but the shorter schedule reduces the number of hospital visits and overall treatment time.
Participants will be randomly assigned to receive either the shorter or standard radiotherapy after surgery. The study will evaluate side effects, treatment effectiveness, and quality of life. The goal is to determine whether the shorter treatment is as safe and effective as the standard approach.
Detailed description
Cervical cancer remains a major health problem, particularly in low- and middle-income countries. Standard postoperative pelvic radiotherapy requires multiple treatment sessions over several weeks, which may limit patient access, increase treatment burden, and prolong overall treatment time. Prolonged treatment duration has been associated with reduced tumor control, and frequent hospital visits may also increase risks for patients, especially during infectious disease outbreaks.
Hypofractionated radiotherapy delivers a higher dose per fraction while maintaining a similar total radiation dose, allowing for a shorter overall treatment course. This approach may improve treatment convenience, reduce healthcare resource utilization, and potentially enhance treatment outcomes without increasing toxicity. However, there is currently limited high-level evidence supporting its use in the postoperative setting for cervical and endometrial cancer.
This study is a phase II randomized controlled trial designed to evaluate the safety and efficacy of postoperative hypofractionated whole pelvic radiotherapy compared with conventional radiotherapy in patients with cervical and endometrial cancer. Participants will be randomly assigned to receive either hypofractionated or standard radiotherapy following surgery.
The study will assess treatment-related toxicity, tumor response, survival outcomes, and quality of life. The results of this study may help establish whether a shorter radiotherapy schedule can be safely implemented as an alternative to standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVRT | Active comparator | Radiation: Conventional RadiotherapyParticipants receive standard postoperative whole pelvic radiotherapy. |
| HYPO | Experimental | Radiation: Hypofractionated RadiotherapyParticipants receive postoperative hypofractionated whole pelvic radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically proven carcinoma of the uterine cervix; and carcinoma and carcinosarcoma of uterine corpus
- Hysterectomy (total abdominal hysterectomy, vaginal hysterectomy, total laparoscopic hysterectomy or radical hysterectomy) for cancer of the cervix or endometrium within 49 days prior to registration. Hence inadvertent surgery will be allowed for inclusion.
- Indicated for adjuvant EBRT from multidisciplinary team discussion.
- Non-metastatic stage according to FIGO 2018 for Cervical cancer and FIGO 2023 for Endometrial cancer and TNM guidelines from appropriate diagnostic workup 4.1 History/physical examination within 45 days prior to registration 4.2 CT/MRI/PET-CT of abdomen/pelvis demonstrating the absence of distant metastasis, performed pre- or post-surgery within 90 days prior to registration 4.3 Chest x-ray or chest CT (or a PET/CT) performed within 90 days prior to registration
- Age ≥18 years old with informed consent
Key exclusion criteria (6 listed)
- Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
- Small cell neuroendocrine cancer, melanoma, uterine sarcoma, and other rare cancers in the cervix and uterus
- Metastatic disease beyond intervertebral disc L2/3 level
- Previous pelvic or abdominal radiotherapy
- Combination of preoperative chemotherapy or radiotherapy with 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 |
|---|---|---|
| Hypofractionated RadiotherapyPostoperative hypofractionated whole pelvic radiotherapy delivered with a higher dose per fraction and a reduced number of treatment sessions compared to conventional radiotherapy, while maintaining a similar total radiation dose. | Radiation | HYPO |
| Conventional RadiotherapyStandard postoperative whole pelvic radiotherapy delivered using conventional fractionation with a lower dose per fraction over a greater number of treatment sessions. | Radiation | CVRT |
Primary outcome
Incidence of Acute Treatment-Related Toxicity
Time frame: During treatment and up to 3 months after completion of radiotherapy
The incidence of acute treatment-related toxicity during radiotherapy and at 1- and 3-month follow-up, assessed using CTCAE version 5.0.
Incidence of Late Treatment-Related Toxicity
Time frame: From 6 months up to 5 years after completion of radiotherapy
The incidence of late (chronic) treatment-related toxicity assessed at 6 and 12 months, and at 3 and 5 years after treatment, using CTCAE version 5.0.
6 secondary outcomes
Tumor Response Rate
Time frame: Up to 12 months after completion of radiotherapy
Quality of Life Assessed by EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Time frame: From baseline up to 5 years after completion of radiotherapy
Local and Nodal Recurrence-Free Survival
Time frame: Up to 5 years after completion of radiotherapy
Distant Metastasis-Free Survival
Time frame: Up to 5 years after completion of radiotherapy
Overall Survival
Time frame: Up to 5 years after completion of radiotherapy.
Incremental Cost-effectiveness Ratio per Quality-adjusted Life Year Between Hypofractionated and Conventional Radiotherapy
Time frame: During treatment and follow-up up to 5 years after completion of radiotherapy.
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 19 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiotherapy and Conventional Radiotherapy in people with Endometrial Cancer and Cervix Cancer, run by Siriraj Hospital at 1 site in Thailand.
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 5 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: looking for participants now, as of the sponsor's last update on 19 May 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 Thailand. 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 Tissana Prasartseree, MD (66625246101, tissana.p@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Treatment-Related Toxicity (time frame: During treatment and up to 3 months after completion of radiotherapy). The study lists 2 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 19 May 2026.