Anal Canal Cancer, Colorectal Cancer, Gastrointestinal Neuroendocrine Tumors, Liver Metastases
Conditions
Keywords
SBRT, radiation, Neoplasm Metastasis, Colorectal Neoplasms, Anal Canal, Neuroendocrine Tumors
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.
Interventions
RADIATIONSBRT
* 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
Sponsors
Instituto do Cancer do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Progression Free Survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 5 years | — |
| Progression Free Survival | 5 years | — |
| Toxicity | 5 years | treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4 |
Countries
Brazil
Contacts
Primary ContactAndre TC Chen, MD, PhD
Backup ContactKarina Moutinho, MD
Outcome results
None listed