Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hypofractionated Brain Radiationcavity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03561896
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Gianfranco Angelo Pesce, Oncology Institute of Southern Switzerland

Brief Summary:
Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases

Condition or disease Intervention/treatment Phase
Brain Metastases, Adult Cancer Brain Radiation: IGRT Radiation: SRS Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: IGRT
Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity
Radiation: IGRT
Image-Guided Radiation Therapy

Experimental: SRS
Stereotactic Radiosurgery of the resection cavity (SRS)
Radiation: SRS
stereotactic radiation therapy




Primary Outcome Measures :
  1. Relapse rate [ Time Frame: 1 year ]
    Evaluate the recurrence probability in the surgical cavity after radiotherapy


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    The proportion of surviving patients at 1 year

  2. 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

  3. Time to neurological progression [ Time Frame: 1 year ]
    Time to neurological deterioration (objective neurological examination and MMSE)

  4. Quality of life assessment [ Time Frame: 1 year ]
    Evaluation of the quality of life through questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03561896


Contacts
Layout table for location contacts
Contact: Gianfranco A Pesce, MD +41918119253 GianfrancoAngelo.pesce@eoc.ch
Contact: Che N Azinwi, MD +41918118932 NgwaChe.Azinwi@eoc.ch

Locations
Layout table for location information
Italy
A.O.U. Città della Salute e della Scienza di Torino Not yet recruiting
Torino, Italy, 10126
Contact: Umberto Ricardi, MD    39 011 6336626    uricardi@unito.it   
Switzerland
Oncology Institute of Southern Switzerland (IOSI) Recruiting
Bellinzona, Ticino, Switzerland, 6500
Contact: Gianfranco A Pesce, MD    +41 (0)91 8118673    GianfrancoAngelo.pesce@eoc.ch   
Universitätsspital Basel Recruiting
Basel, Switzerland, 4031
Contact: Markus Gross, MD    +41 (0)61 2654945    markus.gross@usb.ch   
Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Evelyn Herrmann, MD    +41 (0)31 6322632    evelyn.herrmann@insel.ch   
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8401
Contact: Daniel Zwahlen, MD    +41 (0)52 266 26 45    daniel.zwahlen@ksw.ch   
Klinik Hirslanden Recruiting
Zürich, Switzerland, 8032
Contact: Hansjörg Vees, MD    +41 (0)44 3872550    hansjoerg.vees@hirslanden.ch   
Sponsors and Collaborators
Oncology Institute of Southern Switzerland
Investigators
Layout table for investigator information
Principal Investigator: Gianfranco A Pesce, MD IOSI, Bellinzona, Switzerland

Layout table for additonal information
Responsible Party: Gianfranco Angelo Pesce, MD, Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier: NCT03561896    
Other Study ID Numbers: IOSI-RTO-001
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gianfranco Angelo Pesce, Oncology Institute of Southern Switzerland:
Radation therapy
sterotactic radiosurgery
quality of life
solid cancer
palliation
neurologic functionning
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes