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Recruiting NCT02185443

Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

Phase II Interventional Liver Metastases Colorectal Cancer Anal Canal Cancer Gastrointestinal Neuroendocrine Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SBRT.
Who it may be relevant to
Registry conditions: Liver Metastases, Colorectal Cancer, Anal Canal Cancer, Gastrointestinal Neuroendocrine Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • 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

Primary outcome measures

  • Local Progression Free Survival [Time frame: 2 years]
Secondary outcome measures (3)
  • Overall Survival [Time frame: 5 years]
  • Progression Free Survival [Time frame: 5 years]
  • Toxicity [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Instituto do Cancer do Estado de São Paulo — São Paulo

Identifiers

NCT: NCT02185443 · RT-01/2014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗