NCT02909114
Unknown
Phase 2
Phase II Study of Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
Jing Jin, M.D.1 site in 1 country50 target enrollmentJanuary 2016
ConditionsColorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Jing Jin, M.D.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- local control assessed by RECIST
- Last Updated
- 9 years ago
Overview
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.
Investigators
Jing Jin, M.D.
Medical Doctor
Chinese Academy of Medical Sciences
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)
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
Outcomes
Primary Outcomes
local control assessed by RECIST
Time Frame: 3 years
Secondary Outcomes
- >= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0(from radiotherapy start to complete treatment 90 days)
- overall survival(3 years)
Study Sites (1)
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