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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• The patient is fully voluntary and has the capacity for autonomy, signing the informed consent form 30 days prior to enrollment

• Age ≥18 and ≤75 years

• FIGO stage IB-IIIB cervical cancer; IIIC1 (lymph node metastasis ≤2 cm, without common iliac lymph node metastasis)

• Pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma

• Concurrent weekly cisplatin therapy ± immunotherapy

• Able to undergo brachytherapy

• ECOG performance status of 0-1, with an expected ability to tolerate lying flat for half an hour.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Zheng Zeng, MD.
zengzheng1206@163.com
86-10-6512-4875
Time Frame
Start Date: 2024-11-19
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 440
Treatments
Experimental: Experimental group
Radiotherapy +Concurrent Chemotherapy or Immunotherapy Experimental
Active_comparator: Control group
Radiotherapy +Concurrent Chemotherapy or Immunotherapy Standard of Care
Related Therapeutic Areas
Sponsors
Collaborators: Ruijin Hospital, Shandong Cancer Hospital and Institute, Peking University Cancer Hospital & Institute
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov