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Proton Therapy for Locally Advanced Cervical Cancer

RECRUITINGPhase 2Sponsored by University of Aarhus
Actively Recruiting
PhasePhase 2
SponsorUniversity of Aarhus
Started2024-05-20
Est. completion2029-05-20
Eligibility
Age18 Years – 99 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06462378

Summary

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

Age: 18 Years – 99 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* Inclusion criteria:

  * 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)
  * Para-aortic metastatic nodes below L1-L2 are allowed (FIGO stage IVB)
  * Magnetic Resonance Imaging (MRI) and Positron Emission Tomogaraphy-computerized Tomograpy (PET-CT) of the retroperitoneal space and abdomen at diagnosis
  * Patient written, informed consent
  * Age≥18 years
  * Patients must be able to understand a Danish or Swedish

Exclusion Criteria:

* 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
* Patients receiving neoadjuvant chemotherapy
* Contra indications to MRI
* Contra indications to IGABT
* Contra indications to protontherapy
* Small cell histology (neuroendocrine tumors)
* Active infection or severe medical condition endangering treatment delivery
* Pregnant, lactating or childbearing potential without adequate contraception
* Human Immune Deficiency Virus (HIV)
* Patients with no possibility of follow up

Conditions4

CancerCervical CancerProton TherapyRadiotherapy Side Effect

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