Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy
NCT Number: NCT06509724
Acronym: POHIM-P3
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Uterine Cervical Neoplasms
Interventions: RADIATION: Conventional Fractionated IMRT|RADIATION: Hypofractionated IMRT
Sponsor: Samsung Medical Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 248
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-19
Completion Date: 2032-12-31
Locations: Samsung Medical Center, Seoul, Gangnam-gu, 06351, Korea, Republic of

Summary:
Radical hysterectomy and radiation therapy are standard treatments for cervical cancer. However, there are no reported studies on the frequency of side effects and treatment outcomes when hypofractionated radiation therapy and intensity modulated radiation therapy(IMRT) are used during radiation therapy.

Hypofractionated radiation therapy increases the daily dose and reduces the number of treatment sessions, which may increase the risk of side effects, but its safety has been confirmed in some cases of early cervical cancer and endometrial cancer. Additionally, applying IMRT, a technique designed to protect normal tissue, during concurrent chemoradiotherapy has shown positive results in reducing the incidence of acute side effects.

Investigators previously demonstrated that combining hypofractionated IMRT with chemotherapy for high-risk postoperative cervical cancer patients resulted in high survival rates and low toxicity in a phase 2 exploratory study. Base on this result, this study aimed to compare the efficacy and safety of conventional fractionated radiation therapy and hypofractionated radiation therapy.

Primary Outcome Measures: Local control rate for the radiation treatment area, The percentage of patients who achieve local control of their cervical cancer within the radiation treatment area. Local control is defined as the absence of tumor recurrence or progression in the region., Up to 3 years
Secondary Outcome Measures: Overall survival (OS), The duration of time from the date of randomization until death from any cause. This measure will evaluate the effectiveness of the treatment in prolonging life., Up to 5 years|Disease-free survival (DFS), The length of time from the date of randomization until the occurrence of any signs or symptoms of cervical cancer, such as local recurrence, distant metastasis, or secondary cancer. This measure assesses the efficacy of the treatment in preventing cancer recurrence., Up to 5 years|Acute Toxicity Profile, The incidence and severity of acute treatment-related toxicities, as measured by the Common Terminology Criteria for Adverse Events (CTCAE). Acute toxicities are those occurring within 90days of the start of treatment., During treatment and up to 3 months post-treatment|Late Toxicity Profile, The incidence and severity of late treatment-related toxicities, as measured by the Common Terminology Criteria for Adverse Events (CTCAE). Late toxicities are those occurring more than 90 days after the completion of treatment., From 3 months post-treatment up to 5 years|Quality of life (QoL), Assessment of the patients' quality of life using validated questionnaires such as the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This measure evaluates the impact of treatment on the patients' overall well-being., Baseline, end of treatment, 6 months post-treatment, and annually up to 5 years