Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

NCT02185443 | Recruiting Phase 2

• 1 other identifier: RT-01/2014
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metastases; Colorectal Cancer; Anal Canal Cancer; Gastrointestinal Neuroendocrine Tumors

Keywords

SBRT; radiation; Neoplasm Metastasis; Colorectal Neoplasms; Anal Canal; Neuroendocrine Tumors

Outcome Measures

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.

  2 years

Secondary Outcomes (3)

• Overall Survival

  5 years

• Progression Free Survival

  5 years

• Toxicity

  5 years

Study Arms (1)

SBRT

EXPERIMENTAL

Radiation: SBRT

Interventions

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

Also known as: Stereotactic Body Radiation Therapy

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Karnofsky Performance Scale (KPS) equal or greater than 70
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Instituto do Cancer do Estado de São Paulo: collaborator

Study Sites (1)

Instituto do Cancer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Anal Canal Carcinoma; Neoplasm Metastasis; Neuroendocrine Tumors

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Andre TC Chen, MD, PhD

  Instituto do Cancer do Estado de Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre TC Chen, MD, PhD

CONTACT

55-11- 3893-4540; andre.chen@hc.fm.usp.br

Karina Moutinho, MD

CONTACT

55-11-3893-4542; kamoutinho@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 9, 2014
• Study Start: May 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

BR (1)