Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

Trial Title: Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

NCT ID: NCT02185443

Condition: Liver Metastases
Colorectal Cancer
Anal Canal Cancer
Gastrointestinal Neuroendocrine Tumors

Conditions: Official terms:
Neoplasm Metastasis
Liver Neoplasms
Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms

Conditions: Keywords:
SBRT
radiation
Neoplasm Metastasis
Colorectal Neoplasms
Anal Canal
Neuroendocrine Tumors

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: SBRT
Description: - 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
Arm group label: SBRT

Other name: Stereotactic Body Radiation Therapy

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Instituto do Cancer do Estado de São Paulo

Address:
City: São Paulo
Zip: 01246-000
Country: Brazil

Status: Recruiting

Contact:
Last name: Andre TC Chen, MD

Phone: 55-11-3893-4540
Email: andre.chen@hc.fm.usp.br

Investigator:
Last name: Karina Moutinho, MD
Email: Sub-Investigator

Investigator:
Last name: Rachel Riechelman, MD, PhD
Email: Sub-Investigator

Start date: May 2014

Completion date: December 2026

Lead sponsor:
Agency: University of Sao Paulo
Agency class: Other

Collaborator:
Agency: Instituto do Cancer do Estado de São Paulo
Agency class: Other

Source: University of Sao Paulo

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02185443