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Hypofractionated Brain Radiationcavity

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ClinicalTrials.gov Identifier: NCT03561896
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Gianfranco Angelo Pesce, Oncology Institute of Southern Switzerland

Tracking Information
First Submitted Date  ICMJE January 19, 2017
First Posted Date  ICMJE June 19, 2018
Last Update Posted Date October 26, 2020
Actual Study Start Date  ICMJE January 2015
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
Relapse rate [ Time Frame: 1 year ]
Evaluate the recurrence probability in the surgical cavity after radiotherapy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • Overall survival [ Time Frame: 1 year ]
    The proportion of surviving patients at 1 year
  • Time to systemic progression [ Time Frame: 1 year ]
    The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria
  • Time to neurological progression [ Time Frame: 1 year ]
    Time to neurological deterioration (objective neurological examination and MMSE)
  • Quality of life assessment [ Time Frame: 1 year ]
    Evaluation of the quality of life through questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypofractionated Brain Radiationcavity
Official Title  ICMJE Stereotactic Radiosurgery or Hypofractionated Image-Guided Radiotherapy to the Surgical Cavity After Resection of Brain Metastases: a Multicenter, Single Arm, Open-label, Phase II Trial
Brief Summary Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases
Detailed Description Patients with limited number of brain metastases from solid tumors are at high risk of local recurrence after surgical removal of the tumor mass. The standard Whole-brain radiotherapy (WBRT) demonstrated to reduce the risk of recurrence without improving survival. At the same time WBRT have substantial acute and late toxicity. Preliminary experiences with Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity indicate promising local control and good tolerance. This attitude was only partially explored in prospective trials. In this research patients with limited number of brain metastases and controlled systemic disease will be treated, with such a stereotactic irradiation, at the same time with evaluation of the local control (Primary endpoint) by repeated MRI and of quality of life, neurologic functionning (with a battery of thsts, e.g. MMSE, QLQ-C30, EORTC BN-20) as well as overall survival as secondary endpoints.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Metastases, Adult
  • Cancer Brain
Intervention  ICMJE
  • Radiation: IGRT
    Image-Guided Radiation Therapy
  • Radiation: SRS
    stereotactic radiation therapy
Study Arms  ICMJE
  • Experimental: IGRT
    Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity
    Intervention: Radiation: IGRT
  • Experimental: SRS
    Stereotactic Radiosurgery of the resection cavity (SRS)
    Intervention: Radiation: SRS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Patient underwent surgery for single brain metastasis arising from solid neoplasia (lung, breast, melanoma, kidney, colorectal), with initial histological diagnosis, or selected cases with a resected lesion and a further non-resected lesion (from 1 to 2 lesions), treatable with SRS / IGRT of the surgical cavity
  • Patient ≥ 18 years
  • Willngness to participate in the study, written informed consent
  • Performance Status according to WHO 0-I
  • Good general conditions and organ function
  • Newly diagnosed chemotherapy-naïve disease or controlled systemic disease
  • Good bone marrow, renal and hepatic function
  • Stable steroid dose or reduced for at least 5 days

Exclusion Criteria:

  • History of previous brain irradiation
  • Pregnancy or breastfeeding
  • Histological diagnosis other than lung, breast, melanoma, kidney and colorectal malignancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gianfranco A Pesce, MD +41918119253 GianfrancoAngelo.pesce@eoc.ch
Contact: Che N Azinwi, MD +41918118932 NgwaChe.Azinwi@eoc.ch
Listed Location Countries  ICMJE Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03561896
Other Study ID Numbers  ICMJE IOSI-RTO-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gianfranco Angelo Pesce, Oncology Institute of Southern Switzerland
Study Sponsor  ICMJE Oncology Institute of Southern Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gianfranco A Pesce, MD IOSI, Bellinzona, Switzerland
PRS Account Oncology Institute of Southern Switzerland
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP