Hypofractionated Brain Radiationcavity
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ClinicalTrials.gov Identifier: NCT03561896 |
Recruitment Status :
Recruiting
First Posted : June 19, 2018
Last Update Posted : February 10, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Metastases, Adult Cancer Brain | Radiation: IGRT Radiation: SRS | Not Applicable |
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 : | June 2023 |
Estimated Study Completion Date : | June 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: IGRT
Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity
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Radiation: IGRT
Image-Guided Radiation Therapy |
Experimental: SRS
Stereotactic Radiosurgery of the resection cavity (SRS)
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Radiation: SRS
stereotactic radiation therapy |
- Relapse rate [ Time Frame: 1 year ]Evaluate the recurrence probability in the surgical cavity after radiotherapy
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Gianfranco A Pesce, MD | +41918119253 | GianfrancoAngelo.pesce@eoc.ch | |
Contact: Che N Azinwi, MD | +41918118932 | NgwaChe.Azinwi@eoc.ch |
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: Ekin Ermis, MD +41 (0)31 6322632 ekin.ermis@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 | |
University Hospital Zurich (USZ) | Recruiting |
Zürich, Switzerland | |
Contact: Nicolas Andratschke, MD +41 44 255 37 68 RAO_Akademischesoffice@usz.ch |
Principal Investigator: | Gianfranco A Pesce, MD | IOSI, Bellinzona, Switzerland |
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: | February 10, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Radation therapy sterotactic radiosurgery quality of life |
solid cancer palliation neurologic functionning |
Neoplasm Metastasis Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |