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
Qualifiers
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
Treatments tested in this trial
- Proton therapy
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov