Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients
Information source: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-small Cell Lung Cancer
Intervention: Stereotactic Body Radiotherapy (SBRT) (Radiation); Conventional Radiotherapy (CRT) (Radiation)
Phase: Phase 3
Status: Recruiting
Sponsored by: Ontario Clinical Oncology Group (OCOG) Official(s) and/or principal investigator(s): Anand Swaminath, Principal Investigator, Affiliation: Ontario Clinical Oncology Group (OCOG) Tim Whelan, Principal Investigator, Affiliation: Ontario Clinical Oncology Group (OCOG)
Overall contact: Kathryn Cline, Email: clinek@mcmaster.ca
Summary
A multi-centre randomized controlled open-label trial in medically inoperable patients with
biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting
patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or
conventional radiotherapy (CRT) in a 2: 1 ratio. Radiotherapy will be administered as soon as
possible following randomization and subjects will be followed for 5 years
post-randomization for cancer recurrence, toxicity and survival. The primary outcome is
local control (LC). The trial will be conducted at 16-20 clinical centres throughout Canada.
Clinical Details
Official title: A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Local Control
Secondary outcome: Overall SurvivalDisease-Free Survival Event-Free Survival Lung Cancer-Specific Survival Radiation Treatment-Related Death Toxicity Quality of Life Cost-Utility
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. T1/T2a N0 M0 NSCLC, either by: (a) histological confirmation (squamous cell,
adenocarcinoma, large cell carcinoma, or not specified) and CT thorax and/or PET-CT
evidence, or (b) a suspicious growing nodule on serial CT imaging, with malignant PET
Fluorodeoxyglucose (FDG) avidity, for which a biopsy would be extremely risky.
2. Deemed medically inoperable (as reviewed by a thoracic surgeon and defined as
surgically resectable but, because of underlying physiological medical problems [e. g.
chronic obstructive pulmonary disease (COPD), heart disease], surgery is
contraindicated) or Radiotherapy is preferred by the patient due to high operable
risk.
Exclusion Criteria:
1. Less than 18 years of age.
2. Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
3. Prior invasive malignancy within the past 5 years (excluding non-melanomatous skin
cancer).
4. History of ataxia telangiectasia.
5. Previous radiotherapy (RT) in the vicinity of the tumour, such that significant
overlap could occur.
6. Diagnosis of idiopathic pulmonary fibrosis.
7. Planned for other anticancer therapy (chemotherapy, biological targeted therapy).
8. Female, who is currently pregnant or lactating.
9. Geographic inaccessibility for follow-up.
10. Unable to provide informed consent.
Locations and Contacts
Kathryn Cline, Email: clinek@mcmaster.ca
Tom Baker Cancer Centre, Calgary, Alberta, Canada; Recruiting Harold Lau, Principal Investigator
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada; Recruiting Zsolt Gabos, Principal Investigator
BCCA Vancouver Island Cancer Centre, Victoria, British Columbia, Canada; Recruiting Elaine Wai, Principal Investigator
Cancer Care Manitoba, Winnipeg, Manitoba, Canada; Recruiting Naseer Ahmed, Principal Investigator
Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada; Recruiting Anand Swaminath Anand Swaminath, Principal Investigator
Niagara Health System-Walker Family Cancer Centre, St. Catharines, Ontario, Canada; Recruiting Theos Tsakiridis, Principal Investigator
CHUM Hospital Notre Dame, Montreal, Quebec, Canada; Recruiting Marie-Pierre Campeau, Principal Investigator
Hôpital Maisonneuve-Rosemont, Montreal, Quebec, Canada; Recruiting Alexis Bujold, Principal Investigator
Montreal General Hospital McGill, Montreal, Quebec, Canada; Recruiting Bassam Abdulkarim, Principal Investigator
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada; Recruiting Vijay Kundapur, Principal Investigator
Additional Information
Starting date: February 2014
Last updated: July 30, 2015
|