Actively Recruiting
Proton Therapy for Locally Advanced Cervical Cancer
Led by University of Aarhus · Updated on 2024-06-17
55
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Proton Therapy for Locally Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cancer of the uterine cervix suitable for curative radio- (chemo) therapy including IGABT
- Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix
- Staging according to International 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 allowed (FIGO stage IVB)
- MRI and PET-CT of retroperitoneal space and abdomen at diagnosis
- Patient written, informed consent
- Age 18 years or older
- Able to understand Danish or Swedish
You will not qualify if you...
- 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
- Receiving neoadjuvant chemotherapy
- Contraindications to MRI
- Contraindications to IGABT
- Contraindications to proton therapy
- 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)
- No possibility of follow up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Oncology, Capital Region Denmark
Copenhagen, Denmark
Actively Recruiting
Research Team
H
Hanne Matthiesen, MD, PhD
CONTACT
C
Camilla Kronborg, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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