RecruitingPhase 1Phase 2NCT03315546

Radiotherapy Delivery in Deep Inspiration for Pediatric Patients

Radiotherapy Delivery in Deep Inspiration for Pediatric Patients: TEDDI - a NOPHO Feasibility Study


Sponsor

Rigshospitalet, Denmark

Enrollment

25 participants

Start Date

Jan 1, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

TEDDI is a non-randomised phase II trial in Scandinavia. All pediatric patients, referred for radiotherapy in the thorax or abdomen and irrespective of diagnosis, are eligible. Deep inspiration breath-hold (DIBH) is a simple radiotherapy technique, which could have a dramatic impact on the risk of late effects in children. In DIBH, the radiotherapy is delivered while the patient holds his/her breath (4-6 sequential breath-holds). The anatomy is changed and imaging artifacts from respiratory movement are diminished. DIBH is widely used in adult patients with breast cancer and mediastinal lymphoma to minimize the risk of radiation-induced late effects due to a reduced dose to the healthy organs. Also, the technique is simple and cost-efficient. For pediatric patients, the investigators aim to: * Estimate the dosimetric benefit of radiotherapy using DIBH compared to free-breathing * Establish the compliance of DIBH * Determine if DIBH is an accurate and reproducible strategy * Optimize treatment planning considering the risk from loss of tumour control as well as the risk of late effects.


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Inclusion Criteria4

  • Age 5-17 years.
  • Patients with a tumor in the mediastinum or abdomen with possible need of radiotherapy according to current treatment guidelines, irrespective of cancer diagnosis.
  • The ability to perform three sequential breath-holds of 20 seconds each during the coaching session.
  • Written informed consent from parents or legal guardians.

Exclusion Criteria4

  • Age younger than 5 years or older than 17 years.
  • The need for radiotherapy under general anesthesia.
  • CNS tumor or pelvic localization.
  • Unable to understand coaching information directly or through interpretation.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONradiotherapy delivery in deep-inspiration

Radiotherapy delivery i deep-inspiration versus free-breathing


Locations(3)

Department of Clinical Oncology, Rigshospitalet

Copenhagen, Danmark, Denmark

Department of Clinical Oncology, Aarhus University Hospital

Aarhus, Denmark

Department of Radiation Oncology, Comprehensive Cancer Center, Helsinki University Hospital

Helsinki, Finland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03315546


Related Trials