No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
20 – 85
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
National Taiwan University Hospital · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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 pacli…
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.
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