An interventional study of Hypofractionated Radiotherapy and Conventional Radiotherapy in Endometrial Cancer and Cervix Cancer, sponsored by Siriraj Hospital. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Siriraj Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 120 is above the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Siriraj Hospital is the lead sponsor of 95 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard postoperative whole pelvic radiotherapy.
Radiation: Conventional Radiotherapy
Participants receive postoperative hypofractionated whole pelvic radiotherapy.
Radiation: Hypofractionated Radiotherapy
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.
Standard postoperative whole pelvic radiotherapy delivered using conventional fractionation with a lower dose per fraction over a greater number of treatment sessions.
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.
Time frame: 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.
Time frame: From 6 months up to 5 years after completion of radiotherapy
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years after completion of radiotherapy
Distant Metastasis-Free Survival
Time from treatment completion to distant metastasis
Time frame: Up to 5 years after completion of radiotherapy
Overall Survival
Time from completion of radiotherapy to death from any cause.
Time frame: 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.
Time frame: During treatment and follow-up up to 5 years after completion of radiotherapy.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 195 non-industry interventional studies with no phase under Endometrial Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 76. This study's planned 9 months is below that.
Counting every sponsor, half of 201 studies reached it within 43 months; a quarter within 19 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
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