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Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

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ClinicalTrials.gov Identifier: NCT02185443
Recruitment Status : Recruiting
First Posted : July 9, 2014
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Instituto do Cancer do Estado de São Paulo
Information provided by (Responsible Party):
Andre Tsin Chih Chen, University of Sao Paulo

Brief 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.


Condition or disease Intervention/treatment Phase
Liver Metastases Colorectal Cancer Anal Canal Cancer Gastrointestinal Neuroendocrine Tumors Radiation: SBRT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: SBRT 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
Other Name: Stereotactic Body Radiation Therapy




Primary Outcome Measures :
  1. Local Progression Free Survival [ Time Frame: 2 years ]

    - 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.



Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
  2. Progression Free Survival [ Time Frame: 5 years ]
  3. Toxicity [ Time Frame: 5 years ]
    treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185443


Contacts
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Contact: Andre TC Chen, MD 55-11- 3893-4540 andre.chen@hc.fm.usp.br
Contact: Karina Moutinho, MD 55-11-3893-4542 kamoutinho@gmail.com

Locations
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Brazil
Instituto do Cancer do Estado de São Paulo Recruiting
São Paulo, SP, Brazil, 01246-000
Contact: Andre TC Chen, MD    55-11-3893-4540    andre.chen@hc.fm.usp.br   
Sub-Investigator: Karina Moutinho, MD         
Sub-Investigator: Rachel Riechelman, MD, PhD         
Sponsors and Collaborators
University of Sao Paulo
Instituto do Cancer do Estado de São Paulo
Investigators
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Principal Investigator: Andre TC Chen, MD Instituto do Cancer do Estado de Sao Paulo

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Responsible Party: Andre Tsin Chih Chen, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02185443     History of Changes
Other Study ID Numbers: RT-01/2014
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Keywords provided by Andre Tsin Chih Chen, University of Sao Paulo:
SBRT
radiation
Neoplasm Metastasis
Colorectal Neoplasms
Anal Canal
Neuroendocrine Tumors
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases