Postoperative Hypofractionated Whole Pelvic Radiotherapy in Cervical and Endometrial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiriraj Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hypofractionated Radiotherapy
RadiationPostoperative 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 Radiotherapy
RadiationStandard postoperative whole pelvic radiotherapy delivered using conventional fractionation with a lower dose per fraction over a greater number of treatment sessions.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: CVRTActive comparator 1 intervention
Group B: HYPOExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 radiotherapy2
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 radiotherapySecondary outcomes
1
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 radiotherapy2
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 radiotherapy3
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 radiotherapy4
Distant Metastasis-Free Survival
Time from treatment completion to distant metastasis
Time frame
Up to 5 years after completion of radiotherapySponsors and contacts
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Source ClinicalTrials.gov