PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Jun 1, 2022

Keywords

ClinConnect Summary

The PROTECT trial is studying two types of radiation therapy for women with locally advanced cervical cancer. Specifically, it is comparing intensity-modulated proton therapy (IMPT) with standard radiation therapies like intensity-modulated radiation therapy (IMRT) and volumetric-modulated arc therapy (VMAT). The goal is to see how these treatments affect the amount of radiation delivered to the cancer and any side effects experienced by patients during and after treatment.

To participate in this trial, women must be at least 18 years old and have a confirmed diagnosis of cervical cancer that requires treatment with chemotherapy and radiation. Participants should not have any distant spread of the cancer and must meet certain health criteria to ensure they can tolerate the treatment. If eligible, women can expect to receive advanced radiation therapy as part of their care, and they will be closely monitored throughout the study. It's important to note that the trial is currently recruiting participants and aims to improve treatment options for cervical cancer.

Gender

FEMALE

Eligibility 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 7, 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:
• • Creatinine clearance (\> 50 cc/min)
• • 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:
• • Malignancy treated with curative intent and with no known active disease ≥5 years.
• • 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