RecruitingPhase 3NCT06509724

Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy

Postoperative Conventional Versus Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Multicenter Randomized Phase III Trial (POHIM_P3 Trial)


Sponsor

Samsung Medical Center

Enrollment

248 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation therapy schedules for women with high-risk cervical cancer who have already had radical surgery. It compares a standard longer course of daily radiation to a shorter, higher-dose-per-session schedule (called hypofractionation) to see which is equally effective but more convenient. **You may be eligible if...** - You have been diagnosed with cervical cancer (squamous cell, adenocarcinoma, or adenosquamous) confirmed by biopsy - You have already had radical surgery (hysterectomy and lymph node removal) - Your post-surgical pathology showed at least one high-risk feature: lymph node spread, involvement of tissue around the cervix (parametrium), or cancer at the surgical margin - You are between 20 and 75 years old and in good general health **You may NOT be eligible if...** - You have not had radical surgery for your cervical cancer - Your post-surgical pathology did not show high-risk features requiring radiation - You have poor bone marrow, liver, or kidney function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONConventional Fractionated IMRT

* Dose: 1.8-2.0 Gy per session, total 25-28 sessions (40-50.4Gy) * Chemotherapy: Weekly, total 5-6 sessions

RADIATIONHypofractionated IMRT

* Dose: 2.5 Gy per session, total 16 sessions (40Gy) * Chemotherapy: Weekly, total 3 sessions


Locations(1)

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

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NCT06509724


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