Back to resultsStereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Stereotactic body radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stereotactic boday radiotherapy, oligometastases
Eligibility Criteria
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
Sites / Locations
- Cancer Hospital Chinese Acadamy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
SBRT for oligometastatases from colorectal cancer objectives
Outcomes
Primary Outcome Measures
local control assessed by RECIST
Secondary Outcome Measures
>= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0
overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02909114
Brief Title
Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
Official Title
Phase II Study of Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jing Jin, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer
Detailed Description
Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer, the primary concerns are treatment efficacy and toxicities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stereotactic boday radiotherapy, oligometastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
SBRT for oligometastatases from colorectal cancer objectives
Intervention Type
Radiation
Intervention Name(s)
Stereotactic body radiotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
local control assessed by RECIST
Time Frame
3 years
Secondary Outcome Measure Information:
Title
>= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
from radiotherapy start to complete treatment 90 days
Title
overall survival
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Li, Doctor
Phone
13810381399
Ext
+86
Email
lee_ak@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Jin, Doctor
Phone
13601365130
Ext
+86
Email
jingjin1025@163.com
Facility Information:
Facility Name
Cancer Hospital Chinese Acadamy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li, Doctor
Phone
13810381399
Ext
0086
Email
lee_ak@163.com
First Name & Middle Initial & Last Name & Degree
Jing Jin
Phone
13601365130
Ext
0086
Email
jingjin1025@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
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