Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
NCT ID: NCT02909114
Last Updated: 2016-09-21
Study Results
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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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2016-01-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental group
SBRT for oligometastatases from colorectal cancer objectives
Stereotactic body radiotherapy
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
Interventions
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Stereotactic body radiotherapy
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Pancreatic carcinoma
* Oligometastases could not be located
* Pregnancy or breast feeding
* Symptoms or history of peripheral neuropathy
18 Years
75 Years
ALL
No
Sponsors
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Jing Jin, M.D.
UNKNOWN
Responsible Party
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Jing Jin, M.D.
Medical Doctor
Locations
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Cancer Hospital Chinese Acadamy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CH-GI-096
Identifier Type: -
Identifier Source: org_study_id
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