Postoperative Hypofractionated Whole Pelvic Radiotherapy in Cervical and Endometrial Cancer

Official title

PostOPerative HYPOfractionated Whole Pelvic Radiotherapy in Cervical (Cx) and Endometrial Cancer (PostOP HYPOCxE Trial) : A Phase II Non-inferiority Randomized Controlled Trial

Overview

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

• 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.
• 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.

Primary outcome measures

• Incidence of Acute Treatment-Related Toxicity [Time frame: During treatment and up to 3 months after completion of radiotherapy]
• Incidence of Late Treatment-Related Toxicity [Time frame: From 6 months up to 5 years after completion of radiotherapy]

Secondary outcome measures (6)

• Tumor Response Rate [Time frame: Up to 12 months after completion of radiotherapy]
• Quality of Life Assessed by EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) [Time frame: From baseline up to 5 years after completion of radiotherapy]
• Local and Nodal Recurrence-Free Survival [Time frame: Up to 5 years after completion of radiotherapy]
• Distant Metastasis-Free Survival [Time frame: Up to 5 years after completion of radiotherapy]
• Overall Survival [Time frame: Up to 5 years after completion of radiotherapy.]
• Incremental Cost-effectiveness Ratio per Quality-adjusted Life Year Between Hypofractionated and Conventional Radiotherapy [Time frame: During treatment and follow-up up to 5 years after completion of radiotherapy.]

Eligibility criteria

Inclusion criteria

• 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
• Age ≥18 years old with informed consent

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Thailand · 1 center

• Siriraj Hospital — Bangkok

Identifiers

NCT: NCT07595224 · Si 739/2567(IRB4)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗