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Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

NCT ID: NCT02185443

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Metastases Colorectal Cancer Anal Canal Cancer Gastrointestinal Neuroendocrine Tumors

Keywords

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SBRT radiation Neoplasm Metastasis Colorectal Neoplasms Anal Canal Neuroendocrine Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT

Group Type EXPERIMENTAL

SBRT

Intervention Type 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

Interventions

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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

Intervention Type RADIATION

Other Intervention Names

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Stereotactic Body Radiation Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Andre Tsin Chih Chen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre TC Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cancer do Estado de Sao Paulo

Locations

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Instituto do Cancer do Estado de São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Andre TC Chen, MD, PhD

Role: CONTACT

Phone: 55-11- 3893-4540

Email: [email protected]

Karina Moutinho, MD

Role: CONTACT

Phone: 55-11-3893-4542

Email: [email protected]

Facility Contacts

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Andre TC Chen, MD

Role: primary

Other Identifiers

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RT-01/2014

Identifier Type: -

Identifier Source: org_study_id