cervical cancer cervical cancer
Conditions
Interventions
PT can substantially reduce the unwanted exposure of OAR to radiation dose for women with locally advanced
cervical cancer. The resulting reductions in morbidity have the potential to importantly impr
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of cervical cancer (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, HPV positive or negative) with an indication for curative treatment with primary chemoradiation with concurrent cisplatin followed by 3D image-guided adaptive brachytherapy. - Indication to include the common iliac region (minimum 5, maximum 8) or the common iliac and para-aortic regions (minimum 5, maximum 10) into the elective clinical target volume of the external beam radiotherapy. - No distant metastasis beyond the para-aortic lymph node chain as determined by diagnostic imaging (CT or PET-CT scan) - Age > 18 years - WHO 0-1 - Adequate systemic organ function: o Creatinine clearance (> 50 cc/min) o Adequate bone marrow function : white blood cells (WBCs) >=3.0 x 109/l, neutrophils >=1.5 x 109/l, platelets >=100 x 109/l - Patients must be accessible for treatment and follow-up - Written informed consent according to the local Ethics Committee requirements
Exclusion criteria
Exclusion criteria: - Small cell cancer, melanoma and other rare histological types of the cervix. - History of another primary malignancy that could conceivably be active evaluated by the study physician. Examples of exception include, but are not limited to: o Malignancy treated with curative intent and with no known active disease >=5 years. o Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. - Other severe diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias - Previous pelvic or abdominal radiotherapy - History of active primary immunodeficiency - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn*s disease] - The use of immunosuppressive drugs at baseline - Contraindications for weekly Cisplatin (or Carboplatin) - Contraindications for the use of MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean dose (Gy) to pelvic bones and the mean V15Gy -bowel bag volume (cc) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Compare (IMRT/VMAT) photon with Proton Therapy (IMPT) on: o Dosimetric parameters (target volumes and organs at risk) o Clinical outcomes (response after 3 months, overall survival, pelvic- and distant recurrence-free survival) o Health-related quality of life (EORTC QLQC30 and EORTC QLQCX24/EN24) o Safety & tolerability, grade >=2 according to NCI-CTCAE version 5.0 - Determine the effect of IMPT and IMRT/VMAT on the immune system and possible differences, as measured by the number and function of circulating leukocytes (myeloid cells and lymphocytes). - Evaluation of bone marrow activity using the MRI Dixon sequence. | — |
Countries
Netherlands
Contacts
Public ContactS.M. de Boer
Leids Universitair Medisch Centrum
Outcome results
None listed