Cervical Cancer, Proton Therapy, Radiotherapy Side Effect
Conditions
Brief 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.
Interventions
RADIATIONProton therapy
External beam proton therapy combined with standard cisplatin and brachytherapy
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Proton therapy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Bone marrow toxicity | Worst recorded baseline to 3 months after RT | Grade 2+ Bone marrow toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late bone marrow toxicity | >3 month to 5 years after RT | Grade 2+ Bone marrow toxicity |
| Toxicity | baseline to 5 years after RT | Toxicity evaluated by NCI-CTCAE v. 5.0 (common terminology criteria for adverse events grade 0-5, 5 indicating worse outcome) |
| Patient Reported outcomes | baseline to 5 years after treatment | Patient reported outcomes (by EORTC QLQ-C30, grades 1-4 four indicating worse outcome) |
| Oncological outcomes | 5-year | Progression free survival |
| Dosimetrics outcomes | 3 month | External Beam Radiotherapy dose volume to organs at risk (NCI-CTCAE) and comparison to (Image Guided intensity modulated external beam radiochemotherapy and MRI based adaptive brachy therapy in loaclly advanced cervical cancer) EMBRACE II cohort |
| cisplatin | 3 month | Cummulative dose (mg) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Local control | 5-year | Local tumor control |
| Overall survial | 5-year | Overall survial |
Countries
Denmark
Contacts
Primary ContactHanne Matthiesen, MD, PhD
Backup ContactCamilla Kronborg, MD, PhD
Outcome results
None listed