Actively Recruiting

Phase 2
Age: 18Years - 99Years
FEMALE
NCT06462378

Proton Therapy for Locally Advanced Cervical Cancer

Led by University of Aarhus · Updated on 2024-06-17

55

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Proton Therapy for Locally Advanced Cervical Cancer

Who Can Participate

Age: 18Years - 99Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Cancer of the uterine cervix suitable for curative radio- (chemo) therapy including IGABT
  • Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix
  • Staging according to International 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 allowed (FIGO stage IVB)
  • MRI and PET-CT of retroperitoneal space and abdomen at diagnosis
  • Patient written, informed consent
  • Age 18 years or older
  • Able to understand Danish or Swedish
Not Eligible

You will not qualify if you...

  • 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
  • Receiving neoadjuvant chemotherapy
  • Contraindications to MRI
  • Contraindications to IGABT
  • Contraindications to proton therapy
  • 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)
  • No possibility of follow up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Oncology, Capital Region Denmark

Copenhagen, Denmark

Actively Recruiting

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Research Team

H

Hanne Matthiesen, MD, PhD

CONTACT

C

Camilla Kronborg, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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