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| Name | Class |
|---|---|
| Instituto do Cancer do Estado de São Paulo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 5 years | |
| Progression Free Survival | 5 years | |
| Toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andre TC Chen, MD, PhD | Contact | 55-11- 3893-4540 | andre.chen@hc.fm.usp.br | |
| Karina Moutinho, MD | Contact | 55-11-3893-4542 | kamoutinho@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andre TC Chen, MD, PhD | Instituto do Cancer do Estado de Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Cancer do Estado de São Paulo | Recruiting | São Paulo | São Paulo | 01246-000 | Brazil |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| C563020 | Anal Canal Carcinoma |
| D009362 | Neoplasm Metastasis |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4
| 5 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |