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Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer (ROCK)

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ClinicalTrials.gov Identifier: NCT03520894
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi

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.

Condition or disease Intervention/treatment Phase
Early Breast Cancer Radiation: Neoadjuvant radiotherapy Not Applicable

Detailed Description:
Monocentric, open-label, single-arm phase II study evaluating safety and efficacy of neoadjuvant radiotherapy in early breast cancer patients. Patients eligible are women aged 50 or more years old, affected by histologically proven invasive breast cancer, with positive hormonal receptors, grading 1 or 2, HER-2 negative, without lymphovascular invasion, and tumour size up to 2 cm (measured on mammography, ultrasound or magnetic resonance), negative clinical nodal status, eligible for BCS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiotherapy in Preoperative Setting With CyberKnife as Treatment in Early Breast Cancer: an Explorative Study
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Neoadjuvant radiotherapy arm
Early breast cancer patients eligible for breast conservative surgery will undergo neoadjuvant radiotherapy with Cyberknife robotic system
Radiation: Neoadjuvant radiotherapy
single 21 Gy fraction of Radiotherapy before surgery




Primary Outcome Measures :
  1. Rate of acute skin toxicity events, measured according to RTOG/EORTC scale [ Time Frame: 15 days ]
    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)


Secondary Outcome Measures :
  1. Number of patients with pathologic complete response (pCR) after surgery,according to Chevalier score [ Time Frame: 30 days ]
    Rate of pCR according to Chevalier score

  2. Number of patients with complete resection after surgical excision [ Time Frame: 30 days ]
    Rate of complete resection R0 with margin<1cm (except for deep margin)

  3. Number of patients free from locoregional progression at 36 months [ Time Frame: 36 months ]
    locoregional progression free survival measured at 36 months

  4. Number of patients free from metastatic progression at 36 months [ Time Frame: 36 months ]
    Metastasis progression free survival measured at 36 months

  5. Number of patients dying for breast cancer at 36 months [ Time Frame: 36 months ]
    cause-specific free survival measured at 36 months

  6. Number of patients dying for any cause at 36 months [ Time Frame: 36 months ]
    global survival measured at 36 months

  7. Rate of chronic skin toxicity events, measured according to CTCAE [ Time Frame: 90 days ]

    Incidence of chronic skin toxicity (over 90 days since the end of radiotherapy; fibrosis, telangiectasia, tardive oedema) according to Common terminology criteria for adverse events (CTCAE) v 4.03. From a minimum of 1 (Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated

    • to a maximum of 4 (Life-threatening consequences; urgent intervention indicated

  8. Rate of chronic extra-cutaneous toxicity, measured according to CTCAE [ Time Frame: 90 days ]

    Incidence of chronic extra-skin toxicity (over 90 days from the end of radiotherapy; lung fibrosis, pericarditis, myocardial ischemia, valvulopathy, thoracic wall pain, fracture) according to according to Common terminology criteria for adverse events (CTCAE) v 4.03. From a minimum of 1 (Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated

    • to a maximum of 4 (Life-threatening consequences; urgent intervention indicated

  9. Correlation of differential genetic expression, immunologic and histopathologic features of tumor sample and biomarkers in blood and urine samples with toxicity and rate of response to radiotheraèy [ Time Frame: 60 days ]

    Radiogenomic: confirm of differential genetic expression of genes already validated in previous literature (30-Radiation- induced gene signature; AOI 16-gene breast signature; IRDS gene signature) with Next Generation Sequencing (NGS, RNA-seq) or Real Time PCR on frozen biopsy tissue.

    Immunologic: quantitative analysis of infiltrating leucocytes (MS and M1 macrophages, CD8+ and CD4+ lymphocytes) with immunohistochemistry on fresh biopsy tissue Histopathologic: qualitative analyses (pericytes) and quantitative pattern of vascularization in immunohistochemistry.

    Biochemical: analysis of oxidative stress markers on peripheral blood and urines:

    a) 1 hour before SBRT; b) 1 hour after SBRT; c) 1 week after SBRT; d) during 24 hours before BCS; e) during 2-4 weeks after BCS.




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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Extension of breast disease within 5 mm from the skin surface 2. Tumor size &gt; 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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520894


Contacts
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Contact: Lorenzo Livi, Prof +39 055 7947264 lorenzo.livi@unifi.it
Contact: Icro Meattini, Prof +39 055 7947264 icro.meattini@unifi.it

Locations
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Italy
Azienda Ospedaliero Universitaria Careggi Recruiting
Florence, Italy, 50100
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Investigators
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Study Chair: Lorenzo Livi, Prof AOU Careggi
Study Chair: Icro Meattini, Prof AOU Careggi
Principal Investigator: Giulio Francolini, MD AOU Careggi
Principal Investigator: Vanessa Di Cataldo, MD AOU Careggi

Publications:
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Responsible Party: Lorenzo Livi, Full Professor, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT03520894     History of Changes
Other Study ID Numbers: ROCK
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases