Extended-field proton versus photon therapy for advanced cervical cancer.
Proton Therapy in Extended-field Irradiation for Cervical Cancer
This study tests whether proton therapy can reduce severe lymphopenia and improve survival and side effects compared with photon therapy for people with stage IIIC1 or IIIC2 cervical cancer receiving extended-field radiotherapy.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | Female |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Taipei and 1 other locations) |
| Trial ID | NCT07298642 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort comparing outcomes for patients with stage IIIC1 or IIIC2 cervical cancer who receive extended-field radiotherapy with either proton or photon techniques at two tertiary centers in Taiwan. The study will collect clinical outcomes, radiotherapy-related toxicities, serial lymphocyte counts, and immune cell subsets (CD4, CD8, CD19, CD16+56) at baseline, during treatment, and after treatment. Secondary activities include tissue banking of serum, plasma, and whole blood for future translational research and DNA analysis. Patients undergo approximately nine weeks of radiotherapy and are followed for five years to capture survival and late toxicity outcomes.
Who should consider this trial
Good fit: Adults aged 20–85 with histologically confirmed cervical cancer stage IIIC1 or IIIC2, ECOG performance status 0–1, and judged eligible for extended-field radiotherapy by their treating physician are appropriate candidates.
Not a fit: Patients with distant metastases, prior pelvic or abdominal radiotherapy, severe uncontrolled comorbidities, or other active malignancies within five years are unlikely to be eligible or to benefit from the interventions studied.
Why it matters
Potential benefit: If proton therapy reduces treatment-related lymphopenia, patients could experience fewer immune complications, lower late toxicity, and possibly improved survival.
How similar studies have performed: Smaller planning studies and clinical series suggest protons can better spare normal tissues and reduce radiation exposure to circulating lymphocytes, but definitive randomized evidence showing improved survival in this specific setting is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taipei and 1 other locations
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Jenny Ling-Yu Chen Attending Physician, MD PhD
- Email: ntuhrec@ntuh.gov.tw
- Phone: 886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.