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Proton Therapy for Locally Advanced Cervical Cancer

Proton Therapy for Locally Advanced Cervical Cancer

Recruiting
18-99 years
Female
Phase 2

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Overview

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

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

Study details
    Cervical Cancer
    Proton Therapy
    Radiotherapy Side Effect

NCT06462378

University of Aarhus

21 June 2024

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