Proton Therapy for Locally Advanced Cervical Cancer

Recruiting now · Phase 2

Conditions studied: Cervical Cancer, Proton Therapy, Radiotherapy Side Effect

In brief

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.

Key facts

Study ID

NCT06462378

Run by

University of Aarhus

People needed

55

Starts

2024-05-20

Expected to finish

2034-05-20

Last updated by the study team

2024-06-17

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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