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OPTimizing Irradiation Through Molecular Assessment of Lymph Node (OPTIMAL)

NCT02335957 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 489

Last updated 2022-04-01

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Irradiation

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.

Sponsors & Collaborators

  • Grupo de Investigación Clínica en Oncología Radioterapia

    lead OTHER

Principal Investigators

  • Manuel Algara López, Medicine · Grupo de Investigación Clínica en Oncología Radioterápica (GICOR)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Italy
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT02335957 on ClinicalTrials.gov