Cervical CancerPhase 2/3NCT07298642
Extended-field Proton Therapy for Cervical Cancer
A Phase 2/3 study testing Proton extended field radiation therapy and Photon extended field radiation therapy in people with Cervical Cancer, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Proton extended field radiation therapy and Photon extended field radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesTaiwan
- Study dates
- 30 Sep 2025to May 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jenny Ling-Yu Chen Attending Physician, MD PhD, 886-2-23123456 ext. 262643, ntuhrec@ntuh.gov.tw
Jenny Ling-Yu Chen, MD PhD
- Recruiting
Chang Gung Memorial Hospital
Taoyuan
Chun-Chieh Wang Attending Physician, MD PhD, 886-3-3281200 ext. 2595, isc@cgmh.org.tw
Chun-Chieh Wang, MD PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Proton extended field radiation therapy, Photon extended field radiation therapy
- Keywords
- cervical cancer, proton therapy, extended field
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton extended field radiation therapyRadiation
Proton extended field radiation therapy
Photon extended field radiation therapyRadiation
Photon extended field radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Proton extended-field radiotherapy | Experimental | Proton extended-field radiotherapy Receives: Radiation: Proton extended field radiation therapy |
| Photon extended-field radiotherapy | Active comparator | Photon extended-field radiotherapy Receives: Radiation: Photon extended field radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion
Secondary outcomes (2)
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.
Measured: 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.
Measured: Follow-up for five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start30 Sep 2025
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Extended field radiation therapy (Proton vs Photon)
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298642
- Sponsor's protocol ID
- 202502003RINB
- Other IDs
- TGOG7001
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Therapy in Extended-field Irradiation for Cervical Cancer
- ClinicalTrials.gov ID
- NCT07298642
- Acronym / sponsor ID
- 202502003RINB
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, proton therapy, extended field
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Extended field radiation therapy (Proton vs Photon)
| Arm | Type | Receives |
|---|---|---|
| Proton extended-field radiotherapy | Experimental | Radiation: Proton extended field radiation therapyProton extended-field radiotherapy |
| Photon extended-field radiotherapy | Active comparator | Radiation: Photon extended field radiation therapyPhoton extended-field radiotherapy |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton extended field radiation therapyProton extended field radiation therapy | Radiation | Proton extended-field radiotherapy |
| Photon extended field radiation therapyPhoton extended field radiation therapy | Radiation | Photon extended-field radiotherapy |
Primary outcome
Lymphocyte Counts
Time frame: Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion
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
Immune Cell Subsets
Time frame: Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion
Immune Cell Subsets: The percentage of CD4 (%), CD8 (%), CD19 (%), and CD16+56 (%) will be monitored to assess the immune response to therapy
2 secondary outcomes
Radiotherapy-Related Toxicities
Time frame: Follow-up for five years
Survival outcomes
Time frame: Follow-up for five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Proton extended field radiation therapy and Photon extended field radiation therapy in people with Cervical Cancer, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Ling-Yu Chen Attending Physician, MD PhD (886-2-23123456 ext. 262643, ntuhrec@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphocyte Counts (time frame: Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.