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Radiotherapy Delivery in Deep Inspiration for Pediatric Patients

NCT03315546 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-10-09

No results posted yet for this study

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.

Conditions

  • Pediatric Cancer

Interventions

RADIATION

radiotherapy delivery in deep-inspiration

Radiotherapy delivery i deep-inspiration versus free-breathing

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Tampere University Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2025-12-31
Completion
2029-12-31

Countries

  • Denmark
  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03315546 on ClinicalTrials.gov