Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02909114

Enrollment

Registered

2016-09-21

Start date

2016-01-31

Completion date

2020-12-31

Last updated

2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

stereotactic boday radiotherapy, oligometastases

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.

Interventions

RADIATIONStereotactic 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
local control assessed by RECIST	3 years

Secondary

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

Countries

China

Contacts

Primary ContactNing Li, Doctor

lee_ak@163.com13810381399

Backup ContactJing Jin, Doctor

jingjin1025@163.com13601365130

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026