PROTECT: Prospective Phase-II-Trial Evaluating Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System

External beam radiation therapy (EBRT) with concurrent chemotherapy followed by brachytherapy is a very effective treatment for locally advanced cervical cancer (LACC). However, treatment-related toxicity is common and reduces the patient’s quality of life (QoL) and ability to complete treatment or...

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Bibliographic Details
Published in:Cancers 2021-10, Vol.13 (20), p.5179
Main Authors: Corbeau, Anouk, Nout, Remi A., Mens, Jan Willem M., Horeweg, Nanda, Godart, Jérémy, Kerkhof, Ellen M., Kuipers, Sander C., van Poelgeest, Mariette I. E., Kroep, Judith R., Boere, Ingrid A., van Doorn, Helena C., Hoogeman, Mischa S., van der Heide, Uulke A., Putter, Hein, Welters, Marij J. P., van der Burg, Sjoerd H., Creutzberg, Carien L., de Boer, Stephanie M.
Format: Article
Language:English
Subjects:
Bone marrow
Brachytherapy
Cancer therapies
Cervical cancer
Cervix
Chemotherapy
Cisplatin
Clinical outcomes
Dosimetry
Gynecology
Immune response
Immune system
Lymphatic system
Magnetic resonance imaging
Morbidity
Patients
Quality of life
Radiation therapy
Side effects
Study Protocol
Toxicity
Tumors
Vagina
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Summary:External beam radiation therapy (EBRT) with concurrent chemotherapy followed by brachytherapy is a very effective treatment for locally advanced cervical cancer (LACC). However, treatment-related toxicity is common and reduces the patient’s quality of life (QoL) and ability to complete treatment or undergo adjuvant therapies. Intensity modulated proton therapy (IMPT) enables a significant dose reduction in organs at risk (OAR), when compared to that of standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT). However, clinical studies evaluating whether IMPT consequently reduces side effects for LACC are lacking. The PROTECT trial is a nonrandomized prospective multicenter phase-II-trial comparing clinical outcomes after IMPT or IMRT/VMAT in LACC. Thirty women aged >18 years with a histological diagnosis of LACC will be included in either the IMPT or IMRT/VMAT group. Treatment includes EBRT (45 Gy in 25 fractions of 1.8 Gy), concurrent five weekly cisplatin (40 mg/m2), and 3D image (MRI)-guided adaptive brachytherapy. The primary endpoint is pelvic bones Dmean and mean bowel V15Gy. Secondary endpoints include dosimetric parameters, oncological outcomes, health-related QoL, immune response, safety, and tolerability. This study provides the first data on the potential of IMPT to reduce OAR dose in clinical practice and improve toxicity and QoL for patients with LACC.
ISSN:2072-6694
2072-6694
DOI:10.3390/cancers13205179