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Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer

J

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)

50 participants in 1 patient group

Experimental group
Experimental group
Description:
SBRT for oligometastatases from colorectal cancer objectives
Treatment:
Radiation: Stereotactic body radiotherapy

Trial contacts and locations

1

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Central trial contact

Jing Jin, Doctor; Ning Li, Doctor

Data sourced from clinicaltrials.gov

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