Proton Therapy With Chemotherapy and Brachytherapy for Locally Advanced Cervical Cancer
Tests proton radiation with chemotherapy and internal radiation in adults with advanced cervical cancer.
Plain-language title generated from the registry record
Registry title: Proton Therapy for Locally Advanced Cervical Cancer
Key facts
- Where
- Copenhagen, DenmarkSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT06462378, who can take part
Where in Denmark
- Department of Oncology, Capital Region DenmarkCopenhagen, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT06462378
- Record updated
- 17 June 2024
- Original description
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.Read full original descriptionShow less
Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy
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.
Inclusion: 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: Previous pelvic or abdominal radiotherapy; Combination of preoperative radiotherapy with surgery; Patients receiving neoadjuvant chemotherapy; 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); Active infection or severe medical condition endangering treatment delivery; Human Immune Deficiency Virus (HIV); Contra indications to MRI; Contra indications to IGABT; Contra indications to protontherapy; Small cell histology (neuroendocrine tumors); Pregnant, lactating or childbearing potential without adequate contraception; Patients with no possibility of follow up.