Postoperative Hypofractionated Whole Pelvic Radiotherapy in Cervical and Endometrial Cancer

NCT07595224 | Recruiting

• 1 other identifier: Si 739/2567(IRB4)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometrial Cancer; Cervix Cancer

Keywords

Cervical Cancer; Endometrial Cancer; Hypofractionated Radiotherapy; Whole Pelvic Radiotherapy; Postoperative Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Tumor Response Rate

  Up to 12 months after completion of radiotherapy

• Quality of Life Assessed by EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

  From baseline up to 5 years after completion of radiotherapy

• Local and Nodal Recurrence-Free Survival

  Up to 5 years after completion of radiotherapy

• Distant Metastasis-Free Survival

  Up to 5 years after completion of radiotherapy

• Overall Survival

  Up to 5 years after completion of radiotherapy.

Study Arms (2)

CVRT

ACTIVE COMPARATOR

Participants receive standard postoperative whole pelvic radiotherapy.

Radiation: Conventional Radiotherapy

HYPO

EXPERIMENTAL

Participants receive postoperative hypofractionated whole pelvic radiotherapy.

Radiation: Hypofractionated Radiotherapy

Interventions

Hypofractionated Radiotherapy RADIATION

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.

HYPO

Conventional Radiotherapy RADIATION

Standard postoperative whole pelvic radiotherapy delivered using conventional fractionation with a lower dose per fraction over a greater number of treatment sessions.

CVRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven carcinoma of the uterine cervix; and carcinoma and carcinosarcoma of uterine corpus
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Central Study Contacts

Tissana Prasartseree, MD

CONTACT

66625246101; tissana.p@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 19, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

TH (1)