Proton Therapy for Locally Advanced Cervical Cancer

Phase 2

Recruiting

• Conditions: Cervical Cancer; Proton Therapy; Radiotherapy Side Effect
• Interventions: Radiation: Proton therapy

• Registration Number: NCT06462378
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-20
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Study First Posted: 2024-06-17
• Last Update Posted: 2024-06-17
• Primary Completion: 2029-05-20
• Study Completion: 2034-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton therapy	Proton therapy	Proton therapy

Primary Outcome Measures

Name	Time	Method
Acute Bone marrow toxicity	Worst recorded baseline to 3 months after RT	Grade 2+ Bone marrow toxicity

Secondary Outcome Measures

Name	Time	Method
Patient Reported outcomes	baseline to 5 years after treatment	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)
Toxicity	baseline to 5 years after RT	Toxicity evaluated by NCI-CTCAE v. 5.0 (common terminology criteria for adverse events grade 0-5, 5 indicating worse outcome)
Dosimetrics outcomes	3 month	External Beam Radiotherapy dose volume to organs at risk (NCI-CTCAE) and comparison to (Image Guided intensity modulated external beam radiochemotherapy and MRI based adaptive brachy therapy in loaclly advanced cervical cancer) EMBRACE II cohort
cisplatin	3 month	Cummulative dose (mg)
Oncological outcomes	5-year	Progression free survival
Late bone marrow toxicity	>3 month to 5 years after RT	Grade 2+ Bone marrow toxicity

Trial Locations

Locations (1)

Department of Oncology, Capital Region Denmark; 🇩🇰 Copenhagen, Denmark