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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Denmark
Department of Oncology, Capital Region Denmark
RECRUITING
Copenhagen
Contact Information
Primary
Hanne Matthiesen, MD, PhD
hanne.from.mathiesen@regionh.dk
004592432356
Backup
Camilla Kronborg, MD, PhD
camkro@rm.dk
004592432356
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2034-05-20
Participants
Target number of participants: 55
Treatments
Experimental: Proton therapy
Proton therapy
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus
Collaborators: Aarhus University Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials