The purpose of this protocol is to determine toxicity and efficacy of proton therapy in combination with standard concomitant platinum-based chemotherapy and standard image-guided adaptive brachytherapy (IGABT) in patients with locally advanced cervical cancer (LACC). The over-all aim is to maintain a high disease control and at the same time reduce acute morbidity as well as late side effects after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
External beam proton therapy combined with standard cisplatin and brachytherapy
Department of Oncology, Capital Region Denmark
Copenhagen, Denmark
RECRUITINGAcute Bone marrow toxicity
Grade 2+ Bone marrow toxicity
Time frame: Worst recorded baseline to 3 months after RT
Late bone marrow toxicity
Grade 2+ Bone marrow toxicity
Time frame: >3 month to 5 years after RT
Toxicity
Toxicity evaluated by NCI-CTCAE v. 5.0 (common terminology criteria for adverse events grade 0-5, 5 indicating worse outcome)
Time frame: baseline to 5 years after RT
Patient Reported outcomes
Patient reported outcomes (by EORTC QLQ-C30, grades 1-4 four indicating worse outcome)
Time frame: baseline to 5 years after treatment
Patient Reported outcomes
Patient reported outcomes (by European Organisation for Research and Treatment of Cancer (EORTC) (Quality of life Questionnaire) QLQ-CX24 grades 1-4 four indicating worse outcome)
Time frame: baseline to 5 years after treatment
cisplatin
Cummulative dose (mg)
Time frame: 3 month
Oncological outcomes
Progression free survival
Time frame: 5-year
Dosimetrics outcomes
External Beam Radiotherapy dose volume to organs at risk (NCI-CTCAE) and comparison to (Image Guided intensity modulated external beam radiochemotherapy and MRI based adaptive brachy therapy in loaclly advanced cervical cancer) EMBRACE II cohort
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Time frame: 3 month