Metastasis From Malignant Tumor of Soft TissuesNCT02561559
SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma
An observational study of Metastasis From Malignant Tumor of Soft Tissues, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from STS. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Metastasis From Malignant Tumor of Soft Tissues
- What is being tested?
- Lung metastasis from soft-tissue sarcoma
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2015to Jan 2023
- Phase
- Observational
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients affected by soft-tissue sarcomas with lung metastases unsuitable for surgery
Who may be able to join
- Age 18 anni -85 years
- PS according to ECOG 0-2
- Histopathologically confirmation of soft tissue sarcoma
- Metastatic lung lesion less than 4
- Controlled primary tumor and other metastatic lesions
- Metastatic lesion less than 5 such as the definition of oligometastatic patients
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- Written informed consent
- Contraindication to surgical resection
- Estimated survival ≥ 3 months
- Absence of progressive disease longer than 6 months
- No chemotherapy was given for at least 3 months after SBRT
- Maximum diameter ≤ 5 cm
Who cannot join
- Prior thorax radiation therapy
- Age > 85 years
- PS according to ECOG >2
- Pregnant women
- Maximum diameter ≥ 5.1 cm
- Total volume of lung lesion greater than 1/3 of the whole pulmonary parenchima
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study to Evaluate Feasibility and Safety of Stereotactic Body Radiation Radiotherapy (SBRT) for Lung Metastases From Soft Tissue Sarcoma
In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from STS.
Read the detailed description
The investigators started to treat PM oligometastatic patients with Stereotactic Body Radiotherapy.
The investigators objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from soft-tissue sarcomas. Overall and disease free survival will be evaluated as secondary endpoints.
- Being tested
- Lung metastasis from soft-tissue sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung metastasis from soft-tissue sarcomaRadiation
Tretament based on Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT)
| Study group | Role | What they receive |
|---|---|---|
| Lung metastasis from soft-tissue sarcoma | Lung metastases from soft-tissue sarcoma Receives: Radiation: Lung metastasis from soft-tissue sarcoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control of treated lesions
Evaluation of proportion of patients free from progression from starting radiotherapy
Measured: 12 months
Secondary outcomes (2)
Overall survival of treated patients
Evaluation of proportion of patients alive
Measured: 4 years
Disease free survival of treated patients
Evaluation of proportion of patients alive and free from progression
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study start10 Jun 2015
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastasis From Malignant Tumor of Soft TissuesStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Marta Scorsetti, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561559
- Sponsor's protocol ID
- 1393
- Status last verified
- May 2022
- First submitted
- 25 Sep 2015
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Navarria P, Ascolese AM, Cozzi L, Tomatis S, D'Agostino GR, De Rose F, De Sanctis R, Marrari A, Santoro A, Fogliata A, Cariboni U, Alloisio M, Quagliuolo V, Scorsetti M. Stereotactic body radiation therapy for lung metastases from soft tissue sarcoma. Eur J Cancer. 2015 Mar;51(5):668-74. doi: 10.1016/j.ejca.2015.01.061. Epub 2015 Feb 13.
PubMed 25686482
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate Feasibility and Safety of Stereotactic Body Radiation Radiotherapy (SBRT) for Lung Metastases From Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT02561559
- Acronym / sponsor ID
- 1393
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 28 Sep 2015 (estimated)
- 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.
In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from STS.
Detailed description
The investigators started to treat PM oligometastatic patients with Stereotactic Body Radiotherapy.
The investigators objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from soft-tissue sarcomas. Overall and disease free survival will be evaluated as secondary endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung metastasis from soft-tissue sarcoma | – | Radiation: Lung metastasis from soft-tissue sarcomaLung metastases from soft-tissue sarcoma |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by soft-tissue sarcomas with lung metastases unsuitable for surgery
Key inclusion criteria (12 listed)
- Age 18 anni -85 years
- PS according to ECOG 0-2
- Histopathologically confirmation of soft tissue sarcoma
- Metastatic lung lesion less than 4
- Controlled primary tumor and other metastatic lesions
Key exclusion criteria (6 listed)
- Prior thorax radiation therapy
- Age > 85 years
- PS according to ECOG >2
- Pregnant women
- Maximum diameter ≥ 5.1 cm
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 |
|---|---|---|
| Lung metastasis from soft-tissue sarcomaTretament based on Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) | Radiation | Lung metastasis from soft-tissue sarcoma |
Primary outcome
Local control of treated lesions
Time frame: 12 months
Evaluation of proportion of patients free from progression from starting radiotherapy
2 secondary outcomes
Overall survival of treated patients
Time frame: 4 years
Disease free survival of treated patients
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Background: PubMed 25686482Navarria P, Ascolese AM, Cozzi L, Tomatis S, D'Agostino GR, De Rose F, De Sanctis R, Marrari A, Santoro A, Fogliata A, Cariboni U, Alloisio M, Quagliuolo V, Scorsetti M. Stereotactic body radiation therapy for lung metastases from soft tissue sarcoma. Eur J Cancer. 2015 Mar;51(5):668-74. doi: 10.1016/j.ejca.2015.01.061. Epub 2015 Feb 13.
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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.
Marta Scorsetti, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastasis From Malignant Tumor of Soft Tissues, run by Istituto Clinico Humanitas at 1 site in Italy.
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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
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?
Local control of treated lesions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02561559, which also lists 1 linked publication.
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 4 May 2022.