Liver MetastasesPhase 2NCT02185443
Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
A Phase 2 study testing SBRT in people with Liver Metastases and Colorectal Cancer, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors that are not amenable to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Colorectal Cancer, Anal Canal Cancer
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Karnofsky Performance Scale (KPS) equal or greater than 70
- 1 to 4 liver metastases with an individual maximum diameter of up to 5 cm
- Lesions considered unresectable or patients considered unfit for surgery
- Histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal or gastrointestinal neuroendocrine tumors.
- Absence of evidence of extra-hepatic disease or extra-hepatic disease to be treated with curative intent.
- Minimum interval of 2 weeks between systemic chemotherapy and SBRT.
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- Adequate bone marrow function defined as:
- absolute neutrophils count > 1,800 cells / mm 3
- platelets > 100,000 cells / mm 3
- hemoglobin > 8.0 g / dl ( transfusion or other intervention accepted)
Who cannot join
- Concomitant chemotherapy
- Prior radiotherapy to the upper abdomen
- Pregnancy
- Underlying Cirrhosis
- Active hepatitis or clinically significant liver failure
- Prior invasive neoplasm except for non-melanoma skin cancer, or unless more than five years without evidence of disease
- Severe Comorbidity
- Current anticoagulant treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Cancer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
Andre TC Chen, MD, 55-11-3893-4540, andre.chen@hc.fm.usp.br
Karina Moutinho, MD
About this study
Official title: Stereotactic Body Radiation Therapy for the Treatment of Unresectable Liver Metastases in Patients With Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors
This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of extra-hepatic disease or have disease that is planned to be treated with curative intent.
Therefore, SBRT is being considered as a potentially curative procedure.
- Conditions
- Liver Metastases, Colorectal Cancer, Anal Canal Cancer, Gastrointestinal Neuroendocrine Tumors
- Being tested
- SBRT
- Keywords
- SBRT, radiation, Neoplasm Metastasis, Colorectal Neoplasms, Anal Canal, Neuroendocrine Tumors
- Medical subject headings
- Colorectal Neoplasms, Anal Canal Carcinoma, Neoplasm Metastasis, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Also called Stereotactic Body Radiation Therapy
- 60Gy in 3 fractions (20Gy/fraction) over 14 days
- 60Gy in 5 fractions (12Gy/fraction) over 18 days if organ at risk constraints cannot be met with fractionation above
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | Not described Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Progression Free Survival
- Local Progression Free Survival of treated lesions in evaluable patients. Local Progression Free Survival will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria applied to the Planning Target Volume (PTV) and 1cm around (assessment of marginal failure).
Time-to-events will be counted from the date of initiation of treatment. Patients will be considered evaluable if followed for at least 6 months after SBRT. A review after 6 months is due to the transient changes after irradiation that make uncertain radiological evaluation before 6 months.
Measured: 2 years
Secondary outcomes (3)
Overall Survival
Measured: 5 years
Progression Free Survival
Measured: 5 years
Toxicity
treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto do Cancer do Estado de São Paulo
- Responsible party
- Principal investigator, Andre Tsin Chih Chen, University of Sao Paulo
- Investigators
- Andre TC Chen, MD, PhD, Principal investigator, Instituto do Cancer do Estado de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185443
- Sponsor's protocol ID
- RT-01/2014
- Status last verified
- Dec 2024
- First submitted
- 4 Jul 2014
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy for the Treatment of Unresectable Liver Metastases in Patients With Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT02185443
- Acronym / sponsor ID
- RT-01/2014
- Conditions
- Liver Metastases, Colorectal Cancer, Anal Canal Cancer, Gastrointestinal Neuroendocrine Tumors
- Keywords
- SBRT, radiation, Neoplasm Metastasis, Colorectal Neoplasms, Anal Canal, Neuroendocrine Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Instituto do Cancer do Estado de São Paulo
- Study start
- May 2014
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jul 2014 (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.
This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of extra-hepatic disease or have disease that is planned to be treated with curative intent.
Therefore, SBRT is being considered as a potentially curative procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: SBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Karnofsky Performance Scale (KPS) equal or greater than 70
- 1 to 4 liver metastases with an individual maximum diameter of up to 5 cm
- Lesions considered unresectable or patients considered unfit for surgery
- Histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal or gastrointestinal neuroendocrine tumors.
- Absence of evidence of extra-hepatic disease or extra-hepatic disease to be treated with curative intent.
Key exclusion criteria (8 listed)
- Concomitant chemotherapy
- Prior radiotherapy to the upper abdomen
- Pregnancy
- Underlying Cirrhosis
- Active hepatitis or clinically significant liver failure
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 |
|---|---|---|
| SBRTAlso: Stereotactic Body Radiation Therapy* 60Gy in 3 fractions (20Gy/fraction) over 14 days * 60Gy in 5 fractions (12Gy/fraction) over 18 days if organ at risk constraints cannot be met with fractionation above | Radiation | SBRT |
Primary outcome
Local Progression Free Survival
Time frame: 2 years
- Local Progression Free Survival of treated lesions in evaluable patients. Local Progression Free Survival will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria applied to the Planning Target Volume (PTV) and 1cm around (assessment of marginal failure). Time-to-events will be counted from the date of initiation of treatment. Patients will be considered evaluable if followed for at least 6 months after SBRT. A review after 6 months is due to the transient changes after irradiation that make uncertain radiological evaluation before 6 months.
3 secondary outcomes
Overall Survival
Time frame: 5 years
Progression Free Survival
Time frame: 5 years
Toxicity
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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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.
Andre TC Chen, MD, PhD principal investigator
Instituto do Cancer do Estado de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT in people with Liver Metastases and Colorectal Cancer, run by University of Sao Paulo at 1 site in Brazil.
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 10 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre TC Chen, MD, PhD (55-11- 3893-4540, andre.chen@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Progression Free Survival (time frame: 2 years). 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 9 Dec 2024.