PROTECT: Prospective Phase-II-Trial Evaluating Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System
Cancers, vol. 13, pp. 5179
Abstract
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.
Authors 18
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Leiden University Medical Center
Affiliation as printed
Department of Radiation Oncology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
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Affiliation as printed
Department of Radiotherapy, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands
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Affiliation as printed
Department of Radiotherapy, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Radiation Oncology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
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Erasmus MC Cancer Institute · Holland Particle Therapy Center
Affiliation as printed
Department of Radiotherapy, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands
HollandPTC, Huismansingel 4, 2629 JH Delft, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Radiation Oncology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
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Affiliation as printed
Department of Radiotherapy, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Gynecology and Obstetrics, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
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Erasmus MC · Erasmus MC Cancer Institute
Affiliation as printed
Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands
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Erasmus MC · Erasmus MC Cancer Institute
Affiliation as printed
Department of Gynecological Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands
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Erasmus MC Cancer Institute · Holland Particle Therapy Center
Affiliation as printed
Department of Radiotherapy, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands
HollandPTC, Huismansingel 4, 2629 JH Delft, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Radiation Oncology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Medical Statistics, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
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Leiden University Medical Center · Oncode Institute
Affiliation as printed
Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
Oncode Institute, Jaarbeursplein 6, 3521 AL Utrecht, The Netherlands
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Leiden University Medical Center · Oncode Institute
Affiliation as printed
Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
Oncode Institute, Jaarbeursplein 6, 3521 AL Utrecht, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Radiation Oncology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Radiation Oncology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
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