Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Not Applicable

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00346320
• Lead Sponsor: NCIC Clinical Trials Group

Brief Summary

RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

* Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer.

Secondary

* Determine the toxicities of this regimen in these patients.

* Determine the rates of regional and distant disease recurrence in these patients.

* Determine the progression-free and overall survival of patients treated with this regimen.

* Determine the changes in pulmonary function after treatment in these patients.

* Assess the quality of life of patients after treatment.

OUTLINE: This is a multicenter, prospective study.

Patients undergo accelerated hypofractionated conformal radiotherapy 5 days a week for up to 3 weeks (15 doses) in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at week 3 of radiotherapy, at 1 month after completion of radiotherapy, and then every 4 months for 1 year.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 2006-06-28
• Study First Submitted QC: 2006-06-28
• Study First Posted: 2006-06-29
• Study Start: 2006-08-02
• Primary Completion: 2012-02-28
• Study Completion: 2014-08-20
• Status Verified: 2020-04
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Local tumor control rate at 2 years	2 years	Overall tumor control rate will be assessed at 6 years

Secondary Outcome Measures

Name	Time	Method
Toxicity	6 years
Disease recurrence rates	6 years
Overall survival	6 years
Quality of life	6 years
Changes in pulmonary function	6 years
Progression-free survival	6 years

Trial Locations

Locations (19)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

BCCA - Cancer Centre for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

BCCA - Fraser Valley Cancer Centre; 🇨🇦 Surrey, British Columbia, Canada

BCCA - Vancouver Cancer Centre; 🇨🇦 Vancouver, British Columbia, Canada

BCCA - Vancouver Island Cancer Centre; 🇨🇦 Victoria, British Columbia, Canada

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Atlantic Health Sciences Corporation; 🇨🇦 Saint John, New Brunswick, Canada

Dr. H. Bliss Murphy Cancer Centre; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

Scroll for more (9 remaining)