Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
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|ClinicalTrials.gov Identifier: NCT02185443|
Recruitment Status : Recruiting
First Posted : July 9, 2014
Last Update Posted : May 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Metastases Colorectal Cancer Anal Canal Cancer Gastrointestinal Neuroendocrine Tumors||Radiation: SBRT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Other Name: Stereotactic Body Radiation Therapy
- 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.
- Overall Survival [ Time Frame: 5 years ]
- Progression Free Survival [ Time Frame: 5 years ]
- Toxicity [ Time Frame: 5 years ]treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4
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): NCT02185443
|Contact: Andre TC Chen, MD||55-11- email@example.com|
|Contact: Karina Moutinho, MDfirstname.lastname@example.org|
|Instituto do Cancer do Estado de São Paulo||Recruiting|
|São Paulo, SP, Brazil, 01246-000|
|Contact: Andre TC Chen, MD 55-11-3893-4540 email@example.com|
|Sub-Investigator: Karina Moutinho, MD|
|Sub-Investigator: Rachel Riechelman, MD, PhD|
|Principal Investigator:||Andre TC Chen, MD||Instituto do Cancer do Estado de Sao Paulo|