PROTECT: on-line adaptive proton therapy for cervical cancer to reduce the impact on morbidity and the immune system

Conditions: Cervical cancer

Registration Number: NL-OMON23395

Lead Sponsor: MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

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 or the common iliac and para-aortic regions 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 (PET-CT scan)
-Age > 18 years
-WHO 0-1
-Adequate systemic organ function:
oCreatinine clearance (> 50 cc/min)
oAdequate 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

-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:
oMalignancy treated with curative intent and with no known active disease =5 years.
oAdequately 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Detect a difference of 4.3 Gy in mean dose to pelvic bones (whole pelvic contour), and a difference of 364cc in the mean V15-bowelbag dose (according to EMBRACE bowel bag definition)

Secondary Outcome Measures

Name	Time	Method
-Compare (IMRT/VMAT) photon with Proton Therapy (IMPT) on: <br>oDosimetric parameters (target volumes and organs at risk)<br>oClinical outcomes (response after 3 months, overall survival, pelvic- and distant recurrence-free survival)<br>oHealth-related quality of life (EORTC QLQC30 and EORTC QLQCX24/EN25)<br>oSafety & tolerability, grade =2 according to NCI-CTCAE version 5.0<br>-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 and lymphocytes). <br>