Postoperative Hypofractionated Whole Pelvic Radiotherapy in Cervical and Endometrial Cancer (PostOP HYPOCxE)

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.

Study Overview

• Status: Recruiting
• Conditions: Cervix Cancer; Endometrial Cancer
• Intervention / Treatment: Radiation: Conventional Radiotherapy; Radiation: Hypofractionated Radiotherapy

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tissana Prasartseree, MD; Phone Number: 66625246101; Email: tissana.p@gmail.com

Study Locations

• Thailand
  • Bangkok
    • Bangkok, Bangkok, Thailand
      • Recruiting
      • Siriraj Hospital
      • Contact: Tissana Prasartseree, MD; Phone Number: 66625246101; Email: tissana.p@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathologically proven carcinoma of the uterine cervix; and carcinoma and carcinosarcoma of uterine corpus
2. 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.
3. Indicated for adjuvant EBRT from multidisciplinary team discussion.
4. 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
5. Age ≥18 years old with informed consent

Exclusion Criteria:

1. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
2. Small cell neuroendocrine cancer, melanoma, uterine sarcoma, and other rare cancers in the cervix and uterus
3. Metastatic disease beyond intervertebral disc L2/3 level
4. Previous pelvic or abdominal radiotherapy
5. Combination of preoperative chemotherapy or radiotherapy with surgery
6. Contra-indications to EBRT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CVRT; Participants receive standard postoperative whole pelvic radiotherapy.	Radiation: Conventional Radiotherapy; Standard postoperative whole pelvic radiotherapy delivered using conventional fractionation with a lower dose per fraction over a greater number of treatment sessions.
Experimental: HYPO; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From 6 months up to 5 years after completion of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 5 years after completion of radiotherapy
Distant Metastasis-Free Survival	Time from treatment completion to distant metastasis	Up to 5 years after completion of radiotherapy
Overall Survival	Time from completion of radiotherapy to death from any cause.	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.	During treatment and follow-up up to 5 years after completion of radiotherapy.

Collaborators and Investigators

• Sponsor: Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cervical Cancer; Hypofractionated Radiotherapy; Endometrial Cancer; Postoperative Radiotherapy; Whole Pelvic Radiotherapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Therapeutics; Radiotherapy; Dose Fractionation, Radiation; Radiotherapy Dosage; Radiation Dose Hypofractionation
• Other Study ID Numbers: Si 739/2567(IRB4)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No