Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02185443
• Other study ID #: RT-01/2014
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: University of Sao Paulo
• Contact: Andre TC Chen, MD, PhD
• Phone: 55-11- 3893-4540
• Email: andre.chen[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Canal Cancer
• Colorectal Cancer
• Gastrointestinal Neuroendocrine Tumors
• Intestinal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neuroendocrine Tumors
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Radiation:
• SBRT
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

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Overall Survival		5 years
Secondary	Progression Free Survival		5 years
Secondary	Toxicity	treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4	5 years