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Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

ConditionsLiver MetastasesColorectal CancerAnal Canal CancerGastrointestinal Neuroendocrine Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Concomitant chemotherapy

Prior radiotherapy to the upper abdomen

Pregnancy

Underlying Cirrhosis

Trial design

Design model

Single group

Treatments tested in this trial

  • SBRT

    Radiation

    * 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

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: SBRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

Overall Survival

Time frame
5 years
2

Progression Free Survival

Time frame
5 years
3

Toxicity

treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Collaborator

Source ClinicalTrials.gov
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