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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- University of Sao Paulo
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Local Progression Free Survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SBRT
Intervention: SBRT (Radiation)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall Survival(5 years)
- Progression Free Survival(5 years)
- Toxicity(5 years)
Investigators
Andre Tsin Chih Chen
MD, PhD
University of Sao Paulo