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Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

NCT06641635 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2025-03-18

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Shandong Cancer Hospital and Institute

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2026-10-31
Completion
2029-10-31
FDA Device
Yes

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06641635 on ClinicalTrials.gov