Proton Therapy for Locally Advanced Cervical Cancer

NCT ID: NCT06462378

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2034-05-20

Brief 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.

Conditions

Cervical Cancer; Proton Therapy; Radiotherapy Side Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proton therapy

Proton therapy

Group Type: EXPERIMENTAL

Proton therapy

Intervention Type: RADIATION

External beam proton therapy combined with standard cisplatin and brachytherapy

Interventions

Proton therapy

External beam proton therapy combined with standard cisplatin and brachytherapy

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanne Matthiesen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Capital Region Denmark

Locations

Department of Oncology, Capital Region Denmark

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Hanne Matthiesen, MD, PhD

Role: CONTACT

hanne.from.mathiesen@regionh.dk

004592432356

Camilla Kronborg, MD, PhD

Role: CONTACT

camkro@rm.dk

004592432356

Facility Contacts

Hanne Matthiesen

Role: primary

Other Identifiers

H-22065123

Identifier Type: -

Identifier Source: org_study_id