RecruitingPhase 3NCT06641635

Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

A Multicenter, Non-inferiority, Phase 3, Randomized Controlled Study of Moderated Hypofractionated Online Adaptive Radiotherapy for Cervical Cancer

Sponsor

Peking Union Medical College Hospital

Enrollment

440 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer Adaptive Radiotherapy

Summary

The most common external beam radiotherapy fractionation scheme for cervical cancer is 45-50.4 Gy delivered in 25-28 fractions. However, prolonged treatment duration can lead to insufficient availability of medical resources. We hope to assess the safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with brachytherapy in patients with cervical cancer in a multicenter study.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a modified radiation treatment approach (moderately hypofractionated online adaptive radiotherapy) for cervical cancer — delivering radiation in fewer, slightly larger daily doses while adjusting the treatment plan in real-time to account for day-to-day changes in the body. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with cervical cancer (stages IB to IIIC1 with certain conditions) - Your cancer type is squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma - You are able to receive weekly cisplatin chemotherapy - You can lie flat for at least 30 minutes and tolerate brachytherapy (internal radiation) **You may NOT be eligible if...** - You have had prior surgery for cervical cancer (other than lymph node removal or cone biopsy) - Your cancer is at stage IA, IIIC2, IVA, or IVB - You have had prior radiation to the abdomen or pelvis - You are pregnant or breastfeeding - You have serious heart, kidney, liver, or mental health conditions 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

COMBINATION_PRODUCTModerated hypofractionated online adaptive radiotherapy

Radiation: Moderated hypofractionated online adaptive radiotherapy (oART)+ High-dose rate (HDR) Brachytherapy Experimental group: 43.35Gy/17F external beam radiotherapy with oART + HDR-Brachytherapy Drug: Concurrent Chemotherapy or immunotherapy Weekly cisplatin 40 mg/m2 or PD-1 inhibitors

COMBINATION_PRODUCTConventional radiotherapy

Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Contral group: 45Gy/25F EBRT + HDR-Brachytherapy Drug: Concurrent Chemotherapy or immunotherapy Weekly cisplatin 40 mg/m2 or PD-1 inhibitors