Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer

Jing Jin, M.D.

Status and phase: Unknown; Phase 2

Conditions: Colorectal Cancer

Treatments: Radiation: Stereotactic body radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02909114

CH-GI-096

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Experimental group

Experimental group

Description:

SBRT for oligometastatases from colorectal cancer objectives

Treatment:

Radiation: Stereotactic body radiotherapy