CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 489 enrolled
Drug / intervention
Irradiationradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02335957
NCT02335957N/ACompleted
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OPTimizing Irradiation Through Molecular Assessment of Lymph Node (OPTIMAL)

Grupo de Investigación Clínica en Oncología Radioterapia·interventional·Posted Jan 12, 2015·Updated Apr 1, 2022

In Brief

A clinical study evaluating Irradiation for Breast Cancer. Completed, enrolled 489 participants across 50 sites in 3 countries.

Detailed Summary

The main purpose of this study is to show the non-inferiority of the incidental irradiation, as compared to intentional irradiation of the axillary nodes, in terms of 5-years disease-free survival (DFS) of early stage breast cancer patients with limited affectation of sentinel node assessed by OSNA (250 to 15,000 copies/uL), treated with breast-conservative surgery without axillary lymphadenectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesItaly, Portugal, Spain
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 12, 2015
Enrollment StartApr 1, 2015
Primary CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 11.5 years ago

Interventions

Irradiationradiation

Intentional versus incidental irradiation of lymphatic node areas, administered using a lineal accelerator, after 3D delimitation of the supraclavicular and axillary levels I, II and III. In both treatment arms, further tumoral bed boost will be allowed according to the investigator criteria, whether dose contribution to the nodal areas can be calculated. Due to its nature, interventions cannot be asked.