Extended-field Proton Therapy for Cervical Cancer

NCT ID: NCT07298642

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2030-05-31

Brief Summary

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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

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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.

Conditions

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Cervical Cancer

Keywords

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cervical cancer proton therapy extended field

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Extended field radiation therapy (Proton vs Photon)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Proton extended-field radiotherapy

Proton extended-field radiotherapy

Group Type EXPERIMENTAL

Proton extended field radiation therapy

Intervention Type RADIATION

Proton extended field radiation therapy

Photon extended-field radiotherapy

Photon extended-field radiotherapy

Group Type ACTIVE_COMPARATOR

Photon extended field radiation therapy

Intervention Type RADIATION

Photon extended field radiation therapy

Interventions

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Proton extended field radiation therapy

Proton extended field radiation therapy

Intervention Type RADIATION

Photon extended field radiation therapy

Photon extended field radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Clinical Trial Center

Clinical Associate Professor, Attending Physician, Jenny Ling-Yu Chen MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jenny Ling-Yu Chen Attending Physician, MD PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Jenny Ling-Yu Chen Attending Physician, MD PhD

Role: primary

Chun-Chieh Wang Attending Physician, MD PhD

Role: primary

Other Identifiers

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TGOG7001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202502003RINB

Identifier Type: -

Identifier Source: org_study_id