Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer

Study Overview
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Brief Summary
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Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer

Detailed Description
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Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer, the primary concerns are treatment efficacy and toxicities.

Official Title
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Phase II Study of Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Radiation: Stereotactic body radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1 Diagnosis by pathological examination Primary lesion is under control by surgery Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit (UNL) Urea nitrogen levels ≤1.0× upper normal limit (UNL) Alanine aminotransferase (ALT) ≤1.5× upper normal limit (UNL) Aspartate aminotransferase (AST) ≤1.5× upper normal limit (UNL) Alkaline phosphatase (ALP) ≤1.5× upper normal limit (UNL) Total bilirubin (TBIL) ≤1.5× upper normal limit (UNL) Exclusion Criteria: Primary lesion is not under control Pancreatic carcinoma Oligometastases could not be located Pregnancy or breast feeding Symptoms or history of peripheral neuropathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>SBRT for oligometastatases from colorectal cancer objectives | Radiation: Stereotactic body radiotherapy<br>* All patients will undergo planning CT simulation. 4-dimensional CT will be used for tumors in the lungs or liver. For all lesions, the gross tumor volume (GTV) will be defined as the visible tumor on CT and/or MRI imaging +/- PET. A Planning Target Volume (PTV) margin of 3-5 mm will be added depending on site of disease, immobilization, and institutional set-up accuracy. The prescirbe dosage was as following: Lung lesion DT50-60 Gy/5 fractions; liver 50-60Gy/5-8 fractions; brain DT 40Gy/4-5fractions. All will be treated with SBRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control assessed by RECIST |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| >= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0 |  | from radiotherapy start to complete treatment 90 days | 
| overall survival |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stereotactic boday radiotherapy, oligometastases