Lung Stereotactic Body Radiotherapy (SBRT) Delivered Over 4 Days Versus 11 Days

NCT01620034 | Completed

• 1 other identifier: 106-2010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Stereotactic Body Radiotherapy (SBRT) has emerged as a new treatment option for peripherally located lung tumours, offering very high rates of tumour eradication, with minimal side effects. Even though this treatment option is being adopted in more and more cancer centres, there is still no consensus about the optimal schedule for the radiation treatment. Generally speaking, most lung SBRT schedules involve delivering 3-4 days of radiation. At the Sunnybrook Odette Cancer Centre, the lung SBRT policy is to deliver 4 days of radiation over 11 days (each treatment given once very 3rd day). However, some centres deliver the same treatment over 4 days in a row (each treatment given once daily over 4 days). There is no evidence from the published literature to suggest that there is any difference in side effects between delivering the SBRT over 4 days versus 11 days. To confirm this, the investigators propose to conduct a comparative (randomized) study to compare these 2 approaches.

Conditions

Peripherally Located Stage I Lung Cancer; Peripherally Located Solitary Lung Metastasis

Outcome Measures

Primary Outcomes (1)

• Rate of grade 2 or higher acute toxicity

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

  Within 4 months after completion of therapy

Study Arms (2)

11 Day Arm

ACTIVE COMPARATOR

Radiation: Stereotactic Body Radiotherapy

4 Day Arm

EXPERIMENTAL

Radiation: Stereotactic Body Radiotherapy

Interventions

Stereotactic Body Radiotherapy RADIATION

Patients on the 11 day arm receive 4 fractions of SBRT every 3rd day. Patients on the 4 day arm receive 4 fractions of SBRT every day.

11 Day Arm; 4 Day Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Patrick Cheung, MD, FRCPC

  Toronto Sunnybrook Regional Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 15, 2012
• Study Start: May 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: May 1, 2018
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

CA (1)