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RECRUITING
NCT06641635
PHASE3

Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2024-11-19

Completion Date

2029-10-31

Last Updated

2025-03-18

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Moderated 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_PRODUCT

Conventional 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

Locations (1)

Peking Union Medical College Hospital

Beijing, China