Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02909114
• Other study ID #: CH-GI-096
• Status: Recruiting
• Phase: Phase 2
• First received: September 12, 2016
• Last updated: September 20, 2016
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Ning Li, Doctor
• Phone: 13810381399
• Email: lee_ak[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Acadamy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jing Jin, M.D.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local control assessed by RECIST		3 years	No
Secondary	>= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0		from radiotherapy start to complete treatment 90 days	Yes
Secondary	overall survival		3 years	No