Extended-field Proton Therapy for Cervical Cancer

Proton Therapy in Extended-field Irradiation for Cervical Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Radiation: Proton extended field radiation therapy; Radiation: Photon extended field radiation 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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jenny Ling-Yu Chen Attending Physician, MD PhD; Phone Number: 262643 886-2-23123456; Email: ntuhrec@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Jenny Ling-Yu Chen Attending Physician, MD PhD; Phone Number: 262643 886-2-23123456; Email: ntuhrec@ntuh.gov.tw
    • Principal Investigator: Jenny Ling-Yu Chen, MD PhD
    • Sub-Investigator: Che-Yu Hsu, MD PhD
  • Taoyuan District, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Chun-Chieh Wang Attending Physician, MD PhD; Phone Number: 2595 886-3-3281200; Email: isc@cgmh.org.tw
    • Principal Investigator: Chun-Chieh Wang, MD PhD
    • Sub-Investigator: Po-Jui Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proton extended-field radiotherapy	Radiation: Proton extended field radiation therapy; Proton extended field radiation therapy
Active Comparator: Photon extended-field radiotherapy	Radiation: Photon extended field radiation therapy; Photon extended field radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphocyte Counts	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	Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion
Immune Cell Subsets	Immune Cell Subsets: The percentage of CD4 (%), CD8 (%), CD19 (%), and CD16+56 (%) will be monitored to assess the immune response to therapy	Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiotherapy-Related Toxicities	* Radiotherapy-Related Toxicities: Toxicity levels will be assessed using the CTCAE grading system. Acute and late toxicities will be documented, with a focus on gastrointestinal, hematological, genitourinary, and skin toxicities as part of the comparison between proton and photon therapy.	Follow-up for five years
Survival outcomes	Overall Survival (OS): The time from the start of treatment to death from any cause.; Progression-Free Survival (PFS): The time from the start of treatment to disease progression or death, whichever occurs first. PFS provides insight into the therapeutic efficacy and disease control achieved by each treatment modality.	Follow-up for five years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: cervical cancer; proton therapy; extended field
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: 202502003RINB; TGOG7001 (Other Grant/Funding Number: Taiwanese Gynecologic Oncology Group (TGOG) study)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No