Proton Therapy for Locally Advanced Cervical Cancer

University of Aarhus

Status and phase: Enrolling; Phase 2

Conditions: Radiotherapy Side Effect; Proton Therapy; Cervical Cancer

Treatments: Radiation: Proton therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06462378

H-22065123

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Proton therapy

Experimental group

Description:

Proton therapy

Treatment:

Radiation: Proton therapy