Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer

NCT03520894 | Unknown

• 1 other identifier: ROCK
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to prospectively evaluate, in patients affected by early breast cancer, safety and feasibility of single fraction radiotherapy with Cyberknife R in preoperative setting, and to identify factors predictive for outcome based on biologic and clinical parameters.

Conditions

Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of acute skin toxicity events, measured according to RTOG/EORTC scale

  Acute skin toxicity (from the end of radiotherapy to surgery) according to Radiation Therapy Oncology Group (RTOG)/ European Organization for research and treatment of cancer (EORTC) scale. Measuring acute skin toxicity from a minimum of 0 (no change over baseline) to a maximum of 4 (Ulceration, Hemorrage, necrosis)

  15 days

Secondary Outcomes (9)

• Number of patients with pathologic complete response (pCR) after surgery,according to Chevalier score

  30 days

• Number of patients with complete resection after surgical excision

  30 days

• Number of patients free from locoregional progression at 36 months

  36 months

• Number of patients free from metastatic progression at 36 months

  36 months

• Number of patients dying for breast cancer at 36 months

  36 months

Study Arms (1)

Neoadjuvant radiotherapy arm

EXPERIMENTAL

Early breast cancer patients eligible for breast conservative surgery will undergo neoadjuvant radiotherapy with Cyberknife robotic system

Radiation: Neoadjuvant radiotherapy

Interventions

Neoadjuvant radiotherapy RADIATION

single 21 Gy fraction of Radiotherapy before surgery

Neoadjuvant radiotherapy arm

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Women ≥ 50 years old
• Histological diagnosis of invasive breast cancer
• ER positive (≥ 10% of tumoral cells present ER) and/or PR positive (≥ 10% of tumoral cells present PR)
• Grading 1 or 2
• Her2 negative (IHC 0-1+; in patients with IHC 2+, absence of amplification at FISH
• No lymphovascular invasion evidence at biopsy
• Early breast cancer (T1 N0 M0) clinically and radiologically defined (ultrasound study/ magnetic resonance)
• Patients eligible for BCS.

You may not qualify if:

• Extension of breast disease within 5 mm from the skin surface 2. Tumor size \> 2 cm 3. Patients affected by collagenopathies 4. Patients with BRCA1/2 mutations 5. Previous irradiation to homolateral breast 6. Previous irradiation to homolateral thoracic wall 7. DCIS and/or Paget's disease 8. Psychiatric disorders preventing informed consent signature.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

RECRUITING

Related Publications (2)

• Meattini I, Guenzi M, Fozza A, Vidali C, Rovea P, Meacci F, Livi L. Overview on cardiac, pulmonary and cutaneous toxicity in patients treated with adjuvant radiotherapy for breast cancer. Breast Cancer. 2017 Jan;24(1):52-62. doi: 10.1007/s12282-016-0694-3. Epub 2016 Mar 30.

  PMID: 27025498 BACKGROUND

• Livi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, Saieva C, Paiar F, Scotti V, De Luca Cardillo C, Bastiani P, Orzalesi L, Casella D, Sanchez L, Nori J, Fambrini M, Bianchi S. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Eur J Cancer. 2015 Mar;51(4):451-463. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17.

  PMID: 25605582 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Lorenzo Livi, Prof

  AOU Careggi

  STUDY CHAIR

• Icro Meattini, Prof

  AOU Careggi

  STUDY CHAIR

• Giulio Francolini, MD

  AOU Careggi

  PRINCIPAL INVESTIGATOR

• Vanessa Di Cataldo, MD

  AOU Careggi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Livi, Prof

CONTACT

+39 055 7947264; lorenzo.livi@unifi.it

Icro Meattini, Prof

CONTACT

+39 055 7947264; icro.meattini@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 11, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2024
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)