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Extended-field Proton Therapy for Cervical Cancer
RECRUITINGPhase 2/3Sponsored by National Taiwan University Hospital
Actively Recruiting
PhasePhase 2/3
SponsorNational Taiwan University Hospital
Started2025-09-30
Est. completion2030-05
Eligibility
Age20 Years – 85 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07298642
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
Age: 20 Years – 85 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria: * 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 Criteria: * 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.
Conditions2
CancerCervical Cancer
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Actively Recruiting
PhasePhase 2/3
SponsorNational Taiwan University Hospital
Started2025-09-30
Est. completion2030-05
Eligibility
Age20 Years – 85 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07298642