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Trial Title:
Proton Therapy for Locally Advanced Cervical Cancer
NCT ID:
NCT06462378
Condition:
Cervical Cancer
Proton Therapy
Radiotherapy Side Effect
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Proton therapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Proton therapy
Description:
External beam proton therapy combined with standard cisplatin and brachytherapy
Arm group label:
Proton therapy
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Oncology, Capital Region Denmark
Address:
City:
Copenhagen
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Hanne Matthiesen
Start date:
May 20, 2024
Completion date:
May 20, 2034
Lead sponsor:
Agency:
University of Aarhus
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Source:
University of Aarhus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06462378
