Extended-field proton versus photon therapy for advanced cervical cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.