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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
3-dimensional conformal radiation therapy
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage I or II peripheral disease T1, N0, M0 T2 (≤ 5 cm), N0, M0 T3 (≤ 5 cm, chest wall primary tumor only), N0, M0 No T2-T3 primary tumors > 5 cm or any T1-T3 tumor of the mainstem bronchus involvement No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose) Hilar or mediastinal lymph nodes ≤ 1 cm considered N0 Any of the following primary cancer types: Squamous cell carcinoma Adenocarcinoma Large cell carcinoma Bronchioloalveolar cell carcinoma Non-small cell carcinoma not otherwise specified Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable) Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs No ataxia telangiectasia PATIENT CHARACTERISTICS: ECOG performance status 0-2 Not pregnant or nursing Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply) No active systemic, pulmonary, or pericardial infection No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix. Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer) PRIOR CONCURRENT THERAPY: No prior radiotherapy to the area of the primary tumor No prior or concurrent chemotherapy or immunotherapy for this tumor

Sites / Locations

  • Tom Baker Cancer Centre
  • BCCA - Cancer Centre for the Southern Interior
  • BCCA - Fraser Valley Cancer Centre
  • BCCA - Vancouver Cancer Centre
  • BCCA - Vancouver Island Cancer Centre
  • CancerCare Manitoba
  • Atlantic Health Sciences Corporation
  • Dr. H. Bliss Murphy Cancer Centre
  • QEII Health Sciences Center
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • Cancer Centre of Southeastern Ontario at Kingston
  • London Regional Cancer Program
  • Lakeridge Health Oshawa
  • Thunder Bay Regional Health Science Centre
  • Odette Cancer Centre
  • Hopital Maisonneuve-Rosemont
  • CHUM - Hopital Notre-Dame
  • McGill University - Dept. Oncology
  • CHUQ-Pavillon Hotel-Dieu de Quebec

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy

Arm Description

3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity
Disease recurrence rates
Progression-free survival
Overall survival
Quality of life
Changes in pulmonary function

Full Information

First Posted
June 28, 2006
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00346320
Brief Title
Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Official Title
A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2, 2006 (Actual)
Primary Completion Date
February 28, 2012 (Actual)
Study Completion Date
August 20, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy
Arm Type
Experimental
Arm Description
3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Intervention Description
3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
Primary Outcome Measure Information:
Title
Local tumor control rate at 2 years
Description
Overall tumor control rate will be assessed at 6 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
6 years
Title
Disease recurrence rates
Time Frame
6 years
Title
Progression-free survival
Time Frame
6 years
Title
Overall survival
Time Frame
6 years
Title
Quality of life
Time Frame
6 years
Title
Changes in pulmonary function
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage I or II peripheral disease T1, N0, M0 T2 (≤ 5 cm), N0, M0 T3 (≤ 5 cm, chest wall primary tumor only), N0, M0 No T2-T3 primary tumors > 5 cm or any T1-T3 tumor of the mainstem bronchus involvement No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose) Hilar or mediastinal lymph nodes ≤ 1 cm considered N0 Any of the following primary cancer types: Squamous cell carcinoma Adenocarcinoma Large cell carcinoma Bronchioloalveolar cell carcinoma Non-small cell carcinoma not otherwise specified Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable) Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs No ataxia telangiectasia PATIENT CHARACTERISTICS: ECOG performance status 0-2 Not pregnant or nursing Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply) No active systemic, pulmonary, or pericardial infection No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix. Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer) PRIOR CONCURRENT THERAPY: No prior radiotherapy to the area of the primary tumor No prior or concurrent chemotherapy or immunotherapy for this tumor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick CF Cheung, MD, FRCPC
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sergio L Faria, MD, PhD
Organizational Affiliation
Montreal General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
BCCA - Cancer Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BCCA - Fraser Valley Cancer Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
BCCA - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
BCCA - Vancouver Island Cancer Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Atlantic Health Sciences Corporation
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Dr. H. Bliss Murphy Cancer Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
AIB 3V6
Country
Canada
Facility Name
QEII Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Thunder Bay Regional Health Science Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHUM - Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill University - Dept. Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
CHUQ-Pavillon Hotel-Dieu de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25074417
Citation
Cheung P, Faria S, Ahmed S, Chabot P, Greenland J, Kurien E, Mohamed I, Wright JR, Hollenhorst H, de Metz C, Campbell H, Vu TT, Karvat A, Wai ES, Ung YC, Goss G, Shepherd FA, O'Brien P, Ding K, O'Callaghan C. Phase II study of accelerated hypofractionated three-dimensional conformal radiotherapy for stage T1-3 N0 M0 non-small cell lung cancer: NCIC CTG BR.25. J Natl Cancer Inst. 2014 Jul 29;106(8):dju164. doi: 10.1093/jnci/dju164. Print 2014 Aug. Erratum In: J Natl Cancer Inst. 2015 Jan;107(1): dju430 doi:10.1093/jnci/dju430.
Results Reference
result

Learn more about this trial

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

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