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

Phase 2

Recruiting

Conditions: cervical cancer
10038594

Registration Number: NL-OMON51896

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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 (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

- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean dose (Gy) to pelvic bones and the mean V15Gy -bowel bag volume (cc)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Compare (IMRT/VMAT) photon with Proton Therapy (IMPT) on:<br /><br>o Dosimetric parameters (target volumes and organs at risk)<br /><br>o Clinical outcomes (response after 3 months, overall survival, pelvic- and<br /><br>distant recurrence-free survival)<br /><br>o Health-related quality of life (EORTC QLQC30 and EORTC QLQCX24/EN24)<br /><br>o Safety & tolerability, grade >=2 according to NCI-CTCAE version 5.0<br /><br>- Determine the effect of IMPT and IMRT/VMAT on the immune system and possible<br /><br>differences, as measured by the number and function of circulating leukocytes<br /><br>(myeloid cells and lymphocytes).<br /><br>- Evaluation of bone marrow activity using the MRI Dixon sequence.</p><br>