OPTimizing Irradiation Through Molecular Assesment of Lymph Node After Primary Systemic Treatment

NCT03972696 | Terminated

• 1 other identifier: GIC-RAD-2016-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 20

Brief Summary

Breast cancer management integrating surgery, systemic therapy and radiation therapy tends to systemic treatment as the first therapeutic option, continuing afterwards by surgery and radiation therapy with the scope of decreasing the locoregional treatment. This strategy implies doubts about what should be the locoregional treatment, because many patients have remissions and a significant number of them a complete response. The responses are associated with better clinical outcome although there are doubts about they are a surrogate marker of survival. Nodal irradiation after systemic treatment in patients with breast cancer it is under discussion, particularly in the case of patients with initial clinical involvement experiencing complete remission. For this reason, some groups decide irradiation of all nodal regions and others choose no irradiation of the lymph nodes at all. To clarify this discussion the present study is proposed. The "One Step Nucleic Amplification" (OSNA) is a technique developed by Sysmex Corporation that allows a complete analysis of sentinel nodes and provides a quantification of the tumor marker Cytokeratin 19 (CK19) messenger ribonucleic acid (mRNA) in the sentinel node. The result is expressed by the Tumour Load as number of copies per microliter. This technique has shown its diagnostic ability both without primary systemic treatment and after primary systemic treatment, being more reproducible than conventional processes. In spite of this, fits to mention that the studies of validation used to obtain the European Conformity (CE) mark only included patients without previous systemic treatment to the surgery.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To show the non-inferiority of (BA2) compared to (BA3S), in terms of 5-years diseasefree survival (DFS), including the local, regional and distant disease free survival and excluding second neoplasms

  The primary outcome will be the 5-years DFS. DFS is defined as the time from randomization to any breast cancer-related event, including local, regional or distant recurrence, or death from breast cancer.

  5 years

Secondary Outcomes (3)

• To compare the 5-years incidence of loco-regional tumor recurrence between BA2 and BA3S.

  5 Years

• To compare the 5-years incidence of distant tumor recurrence between BA2 and BA3S

  5 years

• To compare the acute and chronic toxicity of the two treatment modalities.

  5 years

Study Arms (2)

BA3S

ACTIVE COMPARATOR

Radiotherapy (RT) will be administered, in the breast or thoracic wall, axillary levels I, II and III, and supraclavicular node areas, with optimization of the technique Intentional irradiation of lymph nodes: Patients will receive a total dose of 50 Gy in the whole breast and nodal areas (axillary I, II, III, and supraclavicular) with optimization of the technique, in daily fractions of 2 Gy and 5 fractions/week during 5 weeks.

Radiation: Irradiation

BA2

EXPERIMENTAL

RT will be administered, in the breast or thoracic wall and axillary levels I and II, with optimization of the technique Incidental irradiation of lymph nodes: Patients will receive a total dose of 50 Gy in the whole breast, but not aimed at nodal areas, with optimization of the technique, in daily fractions of 2 Gy and 5 fractions/week during 5 weeks.

Radiation: Irradiation

Interventions

Irradiation RADIATION

BA3S versus BA2 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.

BA2; BA3S

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Infiltrating carcinoma of the breast.
• Metastatic lymph nodes (N1) at diagnosis, as determined histologically by Fine Needle Aspiration or Core Needle Biopsy.
• Primary systemic therapy (including antiestrogen or chemotherapy, and targeted therapies).
• Tumour surgery: tumorectomy, quadrantectomy or mastectomy.
• OSNA (ND) or - lymph nodes after primary systemic therapy.
• Age ≥ 18 years old.
• Karnofsky Index ≥ 70 %.
• Signed Informed Consent.

You may not qualify if:

• Lymphadenectomy.
• Bilateral breast cancer.
• Males.
• Previous thoracic irradiation therapy.
• Contraindications of radiotherapy (pregnancy, severe collagen diseases).
• Other neoplasms.
• Severe associated comorbidities that, according to the investigator criteria, may interfere with the study evaluations.
• Lymp nodes OSNA -(L), +, ++ after primary systemic therapy.
• Sentinel lymph node biopsy previous to the primary systemic therapy.
• Mammary internal chain affected.

Sponsors & Collaborators

• Grupo de Investigación Clínica en Oncología Radioterapia: lead

Study Sites (20)

Hospital Universitario de Araba

Vitoria-Gasteiz, Basque Country, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Bilbao, Spain

Location

Hospital Universitario Sant Joan de Reus

Reus, Tarragona, Spain

Location

Centro Oncológico de Galicia

A Coruña, Spain

Location

Hospital Infanta Cristina

Badajoz, Spain

Location

ICO Badalona

Badalona, Spain

Location

Hospital Universitario Santa Lucía

Cartagena, Spain

Location

Hospital Universitario de Donostia

Donostia / San Sebastian, Spain

Location

ICO Girona

Girona, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Universitario Gregrorio Marañón

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital General Universitario de Valencia

Valencia, Spain

Location

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Manuel Algara Lopez, Medicine

  Grupo de Investigación Clínica en Oncología Radioterápica (GICOR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 4, 2019
• Study Start: January 1, 2017
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-09

Locations

ES (20)