Proton Therapy for Locally Advanced Cervical Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cancer of the uterine cervix considered suitable for curative treatment with definitive radio- (chemo) therapy including IGABT
Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
Staging according to Intenational federation of Gynecology and Obstetrics (FIGO) and TNM guidelines
T1-3N1M0 (FIGO stage IIIC1 (with ≥3 pelvic lymph node metastases) and IIIC2)
Disqualifiers
Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
Metastatic disease beyond para-aortic region (L1-L2 interspace)
Previous pelvic or abdominal radiotherapy
Combination of preoperative radiotherapy with surgery
Trial design
Design model
Single group
Treatments tested in this trial
Proton therapy
RadiationExternal beam proton therapy combined with standard cisplatin and brachytherapy
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Proton therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute Bone marrow toxicity
Grade 2+ Bone marrow toxicity
Time frame
Worst recorded baseline to 3 months after RTSecondary outcomes
1
Late bone marrow toxicity
Grade 2+ Bone marrow toxicity
Time frame
>3 month to 5 years after RT2
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 RT3
Patient Reported outcomes
Patient reported outcomes (by EORTC QLQ-C30, grades 1-4 four indicating worse outcome)
Time frame
baseline to 5 years after treatment4
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 treatmentOther outcomes
1
Local control
Local tumor control
Time frame
5-year2
Overall survial
Overall survial
Time frame
5-yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov