Using targeted radiation therapy for liver tumors that can't be surgically removed
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
This study is testing if a special type of radiation therapy can help patients with certain types of cancer who have liver tumors that can't be surgically removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT02185443 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with specific types of cancer who have limited liver metastases and are not candidates for surgery.
Not a fit: Patients with active hepatitis, cirrhosis, or those who have had prior upper abdominal radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a curative option for patients with unresectable liver metastases.
How similar studies have performed: Other studies have shown promising results with SBRT for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
São Paulo, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.