Extended-field Proton Therapy for Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proton extended field radiation therapy, Photon extended field radiation therapy.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: 20 years — 85 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Proton Therapy in Extended-field Irradiation for Cervical Cancer
Overview
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.
Interventions
- Radiation Proton extended field radiation therapy
Proton extended field radiation therapy - Radiation Photon extended field radiation therapy
Photon extended field radiation therapy
Primary outcome measures
- Lymphocyte Counts [Time frame: Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion]
- Immune Cell Subsets [Time frame: Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion]
Secondary outcome measures (2)
- Radiotherapy-Related Toxicities [Time frame: Follow-up for five years]
- Survival outcomes [Time frame: Follow-up for five years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 2 centers
- National Taiwan University Hospital — Taipei
- Chang Gung Memorial Hospital — Taoyuan
Identifiers
NCT: NCT07298642 · 202502003RINB · TGOG7001