Using targeted radiation therapy for liver tumors that can't be surgically removed

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II study evaluates the effectiveness of Stereotactic Body Radiation Therapy (SBRT) in treating liver metastases in patients with colorectal adenocarcinoma, anal canal carcinoma, and gastrointestinal neuroendocrine tumors that are not suitable for surgery. The study focuses on patients with 1 to 4 liver metastases, each measuring up to 5 cm, and aims to determine if SBRT can provide a curative treatment option. Participants must have no evidence of extra-hepatic disease or have such disease planned for curative treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Instituto do Cancer do Estado de São Paulo
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Andre TC Chen, MD, PhD — Instituto do Cancer do Estado de Sao Paulo
• Study coordinator: Andre TC Chen, MD, PhD
• Email: andre.chen@hc.fm.usp.br
• Phone: 55-11- 3893-4540

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.