Clinical trial · Interventional
Extended-field Proton Therapy for Cervical Cancer
Proton Therapy in Extended-field Irradiation for Cervical Cancer
NCT07298642CI-TRIAL-00099507recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photon extended field radiation therapy | Radiation | — | UNRESOLVED |
| Proton extended field radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Proton extended-field radiotherapy
- description
- Proton extended-field radiotherapy
- interventionNames
- Radiation: Proton extended field radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Photon extended-field radiotherapy
- description
- Photon extended-field radiotherapy
- interventionNames
- Radiation: Photon extended field radiation therapy
Primary outcomes (2)
- measure
- Lymphocyte Counts
- timeFrame
- Baseline; Weeks 3-5 of radiotherapy; 2 weeks after radiotherapy completion
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.