Cervix Cancer, Endometrial Cancer
Conditions
Keywords
Cervical Cancer, Endometrial Cancer, Hypofractionated Radiotherapy, Whole Pelvic Radiotherapy, Postoperative Radiotherapy
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.
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.
Interventions
RADIATIONHypofractionated 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.
RADIATIONConventional Radiotherapy
Standard postoperative whole pelvic radiotherapy delivered using conventional fractionation with a lower dose per fraction over a greater number of treatment sessions.
Sponsors
Siriraj Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Acute Treatment-Related Toxicity | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response Rate | Up to 12 months after completion of radiotherapy | Tumor response rate following external beam radiotherapy, assessed during the post-treatment period and at 3-, 6-, and 12-month follow-up. |
| Quality of Life Assessed by EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) | From baseline up to 5 years after completion of radiotherapy | 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. |
| Local and Nodal Recurrence-Free Survival | Up to 5 years after completion of radiotherapy | Time from treatment completion to local or nodal disease recurrence. |
| Distant Metastasis-Free Survival | Up to 5 years after completion of radiotherapy | Time from treatment completion to distant metastasis |
| Overall Survival | Up to 5 years after completion of radiotherapy. | Time from completion of radiotherapy to death from any cause. |
| Incremental Cost-effectiveness Ratio per Quality-adjusted Life Year Between Hypofractionated and Conventional Radiotherapy | During treatment and follow-up up to 5 years after completion of 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. |
Countries
Thailand
Contacts
CONTACTTissana Prasartseree, MD
Outcome results
None listed