Extended-field Proton Therapy for Cervical Cancer

NCT07298642 | Recruiting Phase 2

• 2 other identifiers: 202502003RINBTGOG7001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cervical Cancer

Keywords

cervical cancer; proton therapy; extended field

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Radiotherapy-Related Toxicities

  Follow-up for five years

• Survival outcomes

  Follow-up for five years

Study Arms (2)

Proton extended-field radiotherapy

EXPERIMENTAL

Proton extended-field radiotherapy

Radiation: Proton extended field radiation therapy

Photon extended-field radiotherapy

ACTIVE COMPARATOR

Photon extended-field radiotherapy

Radiation: Photon extended field radiation therapy

Interventions

Proton extended field radiation therapy RADIATION

Proton extended field radiation therapy

Proton extended-field radiotherapy

Photon extended field radiation therapy RADIATION

Photon extended field radiation therapy

Photon extended-field radiotherapy

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Jenny Ling-Yu Chen Attending Physician, MD PhD

CONTACT

886-2-23123456; ntuhrec@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Attending Physician, Jenny Ling-Yu Chen MD PhD

Model Details: Extended field radiation therapy (Proton vs Photon)

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 23, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: December 23, 2025

Record last verified: 2025-11

Locations

TW (2)