Know Cancer

or
forgot password

A Randomized Study of Stereotactic Body Radiotherapy (SBRT) for Lung Tumours Delivered Over 4 Days Versus 11 Days


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Peripherally Located Stage I Lung Cancer, Peripherally Located Solitary Lung Metastasis

Thank you

Trial Information

A Randomized Study of Stereotactic Body Radiotherapy (SBRT) for Lung Tumours Delivered Over 4 Days Versus 11 Days


Inclusion Criteria:



- Pathologic diagnosis of malignancy in the lung (either NSCLC or metastasis)

- If pathologic diagnosis is not available, there must be evidence of FDG uptake on
PET-CT suggestive of malignancy and/or evidence of tumour growth over serial CT scans

- Clinical stage I lung cancer or solitary lung metastasis located in the periphery
away from central mediastinal structures and <=5cm in size

- Patient deemed suitable for lung SBRT (reasonable performance status, acceptable
pulmonary function) by the attending Radiation Oncologist

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of grade 2 or higher acute toxicity

Outcome Description:

CTCAE v4.0 will be used to capture radiotherapy toxicity.

Outcome Time Frame:

Within 4 months after completion of therapy

Safety Issue:

Yes

Principal Investigator

Patrick Cheung, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Odette Cancer Centre

Authority:

Canada: Health Canada

Study ID:

106-2010

NCT ID:

NCT01620034

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Peripherally Located Stage I Lung Cancer
  • Peripherally Located Solitary Lung Metastasis
  • Lung Neoplasms
  • Neoplasm Metastasis

Name

Location