Brain Metastases, AdultNCT03561896
Hypofractionated Brain Radiationcavity
A study testing IGRT and SRS in people with Brain Metastases, Adult and Cancer Brain, run by Oncology Institute of Southern Switzerland at 6 sites in Switzerland.
Trial summary
Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult, Cancer Brain
- What is being tested?
- IGRT and SRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 6 sitesSwitzerland
- Study dates
- Jan 2015to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of previous brain irradiation
- Pregnancy or breastfeeding
- Histological diagnosis other than lung, breast, melanoma, kidney and colorectal malignancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
Universitätsspital Basel
Basel, 4031
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Canton Ticino, 6500
Inselspital
Bern, 3010
Kantonsspital Winterthur
Winterthur, 8401
Klinik Hirslanden
Zurich, 8032
University Hospital Zurich (USZ)
Zurich
About this study
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
Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases
Read the 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.
- Conditions
- Brain Metastases, Adult, Cancer Brain
- Being tested
- IGRT, SRS
- Keywords
- Radation therapy, sterotactic radiosurgery, quality of life, solid cancer, palliation, neurologic functionning
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGRTRadiation
Image-Guided Radiation Therapy
SRSRadiation
stereotactic radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| IGRT | Experimental | Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity Receives: Radiation: IGRT |
| SRS | Experimental | Stereotactic Radiosurgery of the resection cavity (SRS) Receives: Radiation: SRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate
Evaluate the recurrence probability in the surgical cavity after radiotherapy
Measured: 1 year
Secondary outcomes (4)
Overall survival
The proportion of surviving patients at 1 year
Measured: 1 year
Time to systemic progression
The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria
Measured: 1 year
Time to neurological progression
Time to neurological deterioration (objective neurological examination and MMSE)
Measured: 1 year
Quality of life assessment
Evaluation of the quality of life through questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study startJan 2015
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianfranco Angelo Pesce, Oncology Institute of Southern Switzerland
- Investigators
- Gianfranco A Pesce, MD, Principal investigator, IOSI, Bellinzona, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561896
- Sponsor's protocol ID
- IOSI-RTO-001
- Status last verified
- Jul 2024
- First submitted
- 19 Jan 2017
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03561896
- Acronym / sponsor ID
- IOSI-RTO-001
- Conditions
- Brain Metastases, Adult, Cancer Brain
- Keywords
- Radation therapy, sterotactic radiosurgery, quality of life, solid cancer, palliation, neurologic functionning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGRT | Experimental | Radiation: IGRTImage-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity |
| SRS | Experimental | Radiation: SRSStereotactic Radiosurgery of the resection cavity (SRS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- History of previous brain irradiation
- Pregnancy or breastfeeding
- Histological diagnosis other than lung, breast, melanoma, kidney and colorectal malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGRTImage-Guided Radiation Therapy | Radiation | IGRT |
| SRSstereotactic radiation therapy | Radiation | SRS |
Primary outcome
Relapse rate
Time frame: 1 year
Evaluate the recurrence probability in the surgical cavity after radiotherapy
4 secondary outcomes
Overall survival
Time frame: 1 year
Time to systemic progression
Time frame: 1 year
Time to neurological progression
Time frame: 1 year
Quality of life assessment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianfranco A Pesce, MD principal investigator
IOSI, Bellinzona, Switzerland
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IGRT and SRS in people with Brain Metastases, Adult and Cancer Brain, run by Oncology Institute of Southern Switzerland at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.