Proton therapy for advanced cervical cancer

Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy

This study is testing whether combining proton therapy with standard chemotherapy and brachytherapy can help people with advanced cervical cancer while reducing side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years to 99 Years
• Sex: Female
• Sponsor: University of Aarhus (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Copenhagen)
• Trial ID: NCT06462378 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of proton therapy combined with standard platinum-based chemotherapy and image-guided adaptive brachytherapy in patients with locally advanced cervical cancer. The study focuses on maintaining high disease control while minimizing acute and long-term side effects associated with treatment. Participants will undergo imaging assessments and receive treatment according to established cancer staging guidelines.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with locally advanced cervical cancer suitable for curative treatment.

Not a fit: Patients with metastatic disease beyond para-aortic regions or other primary malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and reduce side effects for patients with locally advanced cervical cancer.

How similar studies have performed: Other studies have shown promising results with proton therapy in various cancers, suggesting potential for success in this novel application.

Eligibility criteria

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

Where this trial is running

Copenhagen

• Department of Oncology, Capital Region Denmark — Copenhagen, Denmark (Recruiting)

Study contacts

• Principal investigator: Hanne Matthiesen, MD, PhD — Department of Oncology, Capital Region Denmark
• Study coordinator: Hanne Matthiesen, MD, PhD

Conditions Cervical Cancer; Proton Therapy; Radiotherapy Side Effect