Study Results
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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RECRUITING
PHASE2/PHASE3
44 participants
INTERVENTIONAL
2025-09-30
2030-05-31
Brief Summary
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Detailed Description
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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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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Proton extended-field radiotherapy
Proton extended-field radiotherapy
Proton extended field radiation therapy
Proton extended field radiation therapy
Photon extended-field radiotherapy
Photon extended-field radiotherapy
Photon extended field radiation therapy
Photon extended field radiation therapy
Interventions
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Proton extended field radiation therapy
Proton extended field radiation therapy
Photon extended field radiation therapy
Photon extended field radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
85 Years
FEMALE
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University Clinical Trial Center
Clinical Associate Professor, Attending Physician, Jenny Ling-Yu Chen MD PhD
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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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