Proton Therapy for Locally Advanced Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proton therapy.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Proton Therapy, Radiotherapy Side Effect. Basic parameters: 18 years — 99 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy
Overview
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.
Interventions
- Radiation Proton therapy
External beam proton therapy combined with standard cisplatin and brachytherapy
Primary outcome measures
- Acute Bone marrow toxicity [Time frame: Worst recorded baseline to 3 months after RT]
Secondary outcome measures (7)
- Late bone marrow toxicity [Time frame: >3 month to 5 years after RT]
- Toxicity [Time frame: baseline to 5 years after RT]
- Patient Reported outcomes [Time frame: baseline to 5 years after treatment]
- Patient Reported outcomes [Time frame: baseline to 5 years after treatment]
- cisplatin [Time frame: 3 month]
- Oncological outcomes [Time frame: 5-year]
- Dosimetrics outcomes [Time frame: 3 month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Department of Oncology, Capital Region Denmark — Copenhagen
Identifiers
NCT: NCT06462378 · H-22065123