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

Who is this study for? Patients with Liver Metastases, Colorectal Cancer, Anal Canal Cancer, Gastrointestinal Neuroendocrine Tumors
What treatments are being studied? Stereotactic Body Radiation Therapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Brazil
Instituto do Cancer do Estado de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Andre TC Chen, MD, PhD
andre.chen@hc.fm.usp.br
55-11- 3893-4540
Backup
Karina Moutinho, MD
kamoutinho@gmail.com
55-11-3893-4542
Time Frame
Start Date: 2014-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 43
Treatments
Experimental: SBRT
Authors
Andre TC Chen
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo
Collaborators: Instituto do Cancer do Estado de São Paulo

This content was sourced from clinicaltrials.gov