NCT07298642

Extended-field Proton Therapy for Cervical Cancer

Proton Therapy in Extended-field Irradiation for Cervical Cancer

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Severe lymphopenia is a common complication of extended-field radiotherapy in cervical cancer, significantly impacting immune function and clinical outcomes. This study aims to evaluate whether proton therapy, with its superior dose distribution, can reduce lymphopenia and improve survival and toxicity profiles compared to photon therapy.

Detailed description

This study is a prospective, observational cohort study designed to evaluate the effects of proton therapy and photon therapy in patients with stage IIIC1 or IIIC2 cervical cancer undergoing extended-field radiotherapy. Primary data collection will include clinical outcomes, radiotherapy-related toxicities, lymphocyte counts, and immune cell subsets (e.g., CD4, CD8, CD19, and CD16+56), measured at baseline, during treatment, and post-treatment. Secondary data collection will involve tissue banking for future translational research projects, including serum, plasma, and whole blood for DNA analysis. The study will be conducted in two tertiary cancer centers (CGMH and NTUCC), with individual patient participation proton or photon treatment approximately 9 weeks, followed by an additional five years for long-term follow-up to assess survival outcomes and late toxicities. This design enables robust comparison of the therapeutic impact of proton and photon therapies on clinical and immunological endpoints, providing evidence to guide personalized treatment decisions in cervical cancer.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
RADIATION	Proton extended field radiation therapy	Proton extended field radiation therapy
RADIATION	Photon extended field radiation therapy	Photon extended field radiation therapy

Timeline

• Start date: 2025-09-30
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2025-12-23
• Last updated: 2025-12-23

Locations

2 sites across 1 country: Taiwan