NCT03121248 (HAI-5-III) is a NA clinical trial of WBI 5 fractions in Breastcancer, sponsored by University Hospital, Ghent.

Who is sponsoring NCT03121248?

NCT03121248 is sponsored by University Hospital, Ghent.

What drugs are being tested in NCT03121248?

Interventions in NCT03121248: WBI 5 fractions, WBI 15 fractions, LNI 5 fractions, LNI 15 fractions, SIB 5 fractions if needed, SIB 15 fractions if needed, TWI 5 fractions, TWI 15 fractions.

What condition does NCT03121248 study?

NCT03121248 studies Breastcancer.

Is NCT03121248 still recruiting?

NCT03121248 is currently active, enrolled. Last updated 22 December 2023.

Last reviewed 2023-12-22 · How we verify

NCT03121248: HAI-5-III

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years

Active, enrolled NA Last updated 22 December 2023

What this trial tests

NA trial testing WBI 5 fractions in Breastcancer in 144 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 February 2017

Primary endpoint
15 November 2021

15 November 2026

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	144
Start date	15 February 2017
Primary completion	15 November 2021
Estimated completion	15 November 2026
Sites	1 location across Belgium

Drugs / interventions tested

WBI 5 fractions
WBI 15 fractions
LNI 5 fractions
LNI 15 fractions
SIB 5 fractions if needed
SIB 15 fractions if needed
TWI 5 fractions
TWI 15 fractions

Conditions studied

Breastcancer — all drugs for Breastcancer →

Sponsor

University Hospital, Ghent

Who can join

65 and older, female only, with Breastcancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the effect of highly accelerated external beam radiotherapy (EBRT) in 5 fractions over 10 days compared to 15 fractions over 3 weeks for early as well as locally-advanced stage breast cancer. Primary endpoint will be chronic toxicity (breast deformation and retraction). Secondary endpoints are acute toxicity, loco-regional and distant tumor control, patient reported QoL and cosmetic satisfaction. Patients with lymph node irradiation will be closely monitored for radiation induced plexopathy.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Ultra-hypofractionated one-week locoregional radiotherapy for patients with early breast cancer: Acute toxicity results.
Ratosa I, Montero A, Ciervide R, Alvarez B, et al · · 2024 · cited 6× · PMID 38516338 · DOI 10.1016/j.ctro.2024.100764
Breast Cancer Adjuvant Radiotherapy and Chemotherapy Sequencing: Sequential, Concomitant, or What Else? A Comprehensive Review of the Adjuvant Combinations Journey.
Lazzari G, Montagna A, D'Andrea B, Bianculli A, et al · · 2024 · cited 5× · PMID 39458200 · DOI 10.3390/jcm13206251
The 2024 Assisi think tank on breast cancer: Focus on the use of a tumour bed boost after breast conserving therapy.
Arenas M, Bölükbaşı Y, Boersma LJ, Offersen B, et al · · 2025 · cited 2× · PMID 39854807 · DOI 10.1016/j.breast.2025.103881

Verify or expand the search:

Other University Hospital, Ghent trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03121248 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Ghent
Last refreshed: 22 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03121248.

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