Proton extended field radiation therapyPhoton extended field radiation therapy
Proton extended field radiation therapy: Proton extended field radiation therapy
Photon extended field radiation therapy: Photon extended field radiation therapy
Study 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
FEMALE
Min age
20 Years
Max age
85 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Lymphocyte Counts — Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion Lymphocyte Counts: The absolute lymphocyte count will be measured pre-treatment, during treatment, and post-treatment. Severe lymphopenia is defined as an absolute lymphocyte count \<500/μL
Immune Cell Subsets — Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion Immune Cell Subsets: The percentage of CD4 (%), CD8 (%), CD19 (%), and CD16+56 (%) will be monitored to assess the immune response to therapy
Trial sites (2)
Facility
City
Region
Status
National Taiwan University Hospital
Taipei
Taiwan
Recruiting
Chang Gung Memorial Hospital
Taoyuan
Taiwan
Recruiting
More National Taiwan University Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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