RecruitingPhase 2Phase 3NCT07298642
Extended-field Proton Therapy for Cervical Cancer
Proton Therapy in Extended-field Irradiation for Cervical Cancer
Sponsor
National Taiwan University Hospital
Enrollment
44 participants
Start Date
Sep 30, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 20 YearsMax Age: 85 Years
Inclusion Criteria7
- Histologically confirmed cervical cancer, stage ≥ IIIC.
- Age between 20 and 85 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Eligible for extended-field radiotherapy as determined by the treating physician.
- Induction chemotherapy with paclitaxel and carboplatin is allowed if the duration is ≤ 6 weeks or ≤ 2 cycles.
- RT alone, or concurrent single-agent chemotherapy with weekly cisplatin or carboplatin during radiation therapy is allowed, while the use of any other concurrent antineoplastic agents is prohibited.
- Consolidative chemotherapy or immunotherapy after radiation therapy is allowed.
Exclusion Criteria5
- Prior history of pelvic or abdominal radiotherapy.
- Presence of distant metastases or other active malignancies within the past 5 years, excluding non-melanoma skin cancer.
- Severe comorbid conditions, such as uncontrolled diabetes, cardiovascular disease, or autoimmune disorders, that may interfere with treatment or study participation.
- Pregnancy or breastfeeding at the time of enrollment.
- Psychiatric or social conditions that would limit compliance with study requirements or follow-up.
Interventions
RADIATIONProton extended field radiation therapy
Proton extended field radiation therapy
RADIATIONPhoton extended field radiation therapy
Photon extended field radiation therapy
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07298642
Related Trials
ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors
NCT0697316127 locations
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
NCT049774538 locations
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
NCT0721670360 locations
A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
NCT06459180239 locations
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
NCT0695266078 locations