NCT02185443 Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
| NCT ID | NCT02185443 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Sao Paulo |
| Condition | Liver Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2014-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 43 participants in total. It began in 2014-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. * 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) Exclusion Criteria: * 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
Contact & Investigator
Andre TC Chen, MD, PhD
PRINCIPAL INVESTIGATOR
Instituto do Cancer do Estado de Sao Paulo
Frequently Asked Questions
Who can join the NCT02185443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02185443 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02185443 currently recruiting?
Yes, NCT02185443 is actively recruiting participants. Contact the research team at andre.chen@hc.fm.usp.br for enrollment information.
Where is the NCT02185443 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT02185443 clinical trial?
NCT02185443 is sponsored by University of Sao Paulo. The principal investigator is Andre TC Chen, MD, PhD at Instituto do Cancer do Estado de Sao Paulo. The trial plans to enroll 43 participants.