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

Who is this study for? Patients with Pediatric Cancer
What treatments are being studied? Radiotherapy Delivery in Deep-Inspiration
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Department of Clinical Oncology, Aarhus University Hospital
RECRUITING
Aarhus
Department of Clinical Oncology, Rigshospitalet
RECRUITING
Copenhagen
Finland
Department of Radiation Oncology, Comprehensive Cancer Center, Helsinki University Hospital
RECRUITING
Helsinki
Contact Information
Primary
Maja V Maraldo, MD, PhD
maja.vestmoe.maraldo@regionh.dk
Backup
Anni YS Jørgensen, MD
anni.young.lundgaard@regionh.dk
Time Frame
Start Date: 2017-01-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 25
Related Therapeutic Areas
Sponsors
Collaborators: Tampere University Hospital, Helsinki University Central Hospital, Aarhus University Hospital
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov