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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 Survival

Disease-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

Page last updated: August 23, 2015

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