Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Radiation: Stereotactic body radiotherapy

• Registration Number: NCT02909114
• Lead Sponsor: Jing Jin, M.D.

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.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-20
• Last Update Submitted: 2016-09-20
• Study First Posted: 2016-09-21
• Last Update Posted: 2016-09-21
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Stereotactic body radiotherapy	SBRT for oligometastatases from colorectal cancer objectives

Primary Outcome Measures

Name	Time	Method
local control assessed by RECIST	3 years

Secondary Outcome Measures

Name	Time	Method
>= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0	from radiotherapy start to complete treatment 90 days
overall survival	3 years

Trial Locations

Locations (1)

Cancer Hospital Chinese Acadamy of Medical Sciences; 🇨🇳 Beijing, Beijing, China