Clinical trial · Interventional
Proton Therapy for Locally Advanced Cervical Cancer
Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy
- 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)
The purpose of this protocol is to determine toxicity and efficacy of proton therapy in combination with standard concomitant platinum-based chemotherapy and standard image-guided adaptive brachytherapy (IGABT) in patients with locally advanced cervical cancer (LACC). The over-all aim is to maintain a high disease control and at the same time reduce acute morbidity as well as late side effects after treatment.
Conditions
Conditions (3)
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 |
| Proton Therapy | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton therapy
- description
- Proton therapy
- interventionNames
- Radiation: Proton therapy
Primary outcomes (1)
- measure
- Acute Bone marrow toxicity
- timeFrame
- Worst recorded baseline to 3 months after RT
- description
- Grade 2+ Bone marrow toxicity
Secondary outcomes (7)
- measure
- Late bone marrow toxicity
- timeFrame
- >3 month to 5 years after RT
- description
- Grade 2+ Bone marrow toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion criteria: * Cancer of the uterine cervix considered suitable for curative treatment with definitive radio- (chemo) therapy including IGABT * Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. * Staging according to Intenational federation of Gynecology and Obstetrics (FIGO) and TNM guidelines * T1-3N1M0 (FIGO stage IIIC1 (with ≥3 pelvic lymph node metastases) and IIIC2) * Para-aortic metastatic nodes below L1-L2 are allowed (FIGO stage IVB) * Magnetic Resonance Imaging (MRI) and Positron Emission Tomogaraphy-computerized Tomograpy (PET-CT) of the retroperitoneal space and abdomen at diagnosis * Patient written, informed consent * Age≥18 years * Patients must be able to understand a Danish or Swedish Exclusion Criteria: * Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin * Metastatic disease beyond para-aortic region (L1-L2 interspace) * Previous pelvic or abdominal radiotherapy * Combination of preoperative radiotherapy with surgery * Patients receiving neoadjuvant chemotherapy * Contra indications to MRI * Contra indications to IGABT * Contra indications to protontherapy * Small cell histology (neuroendocrine tumors) * Active infection or severe medical condition endangering treatment delivery * Pregnant, lactating or childbearing potential without adequate contraception * Human Immune Deficiency Virus (HIV) * Patients with no possibility of follow up
References
Publications (0)
Data not yet available