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

August 3, 2023 updated by: NCIC Clinical Trials Group

A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BCCA - Cancer Centre for the Southern Interior
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BCCA - Fraser Valley Cancer Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA - Vancouver Cancer Centre
      • Victoria, British Columbia, Canada, V8R 6V5
        • BCCA - Vancouver Island Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Atlantic Health Sciences Corporation
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, AIB 3V6
        • Dr. H. Bliss Murphy Cancer Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • QEII Health Sciences Center
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Science Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM - Hopital Notre-Dame
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University - Dept. Oncology
      • Montreal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneuve-Rosemont
      • Quebec City, Quebec, Canada, G1R 2J6
        • CHUQ-Pavillon Hotel-Dieu de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy
3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
Radiation: 3-dimensional conformal radiation therapy
3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local tumor control rate at 2 years
Time Frame: 2 years
Overall tumor control rate will be assessed at 6 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 6 years
6 years
Toxicity
Time Frame: 6 years
6 years
Disease recurrence rates
Time Frame: 6 years
6 years
Progression-free survival
Time Frame: 6 years
6 years
Quality of life
Time Frame: 6 years
6 years
Changes in pulmonary function
Time Frame: 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Investigators

  • Study Chair: Patrick CF Cheung, MD, FRCPC, Toronto Sunnybrook Regional Cancer Centre
  • Study Chair: Sergio L Faria, MD, PhD, Montreal General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2006

Primary Completion (Actual)

February 28, 2012

Study Completion (Actual)

August 20, 2014

Study Registration Dates

First Submitted

June 28, 2006

First Submitted That Met QC Criteria

June 28, 2006

First Posted (Estimated)

June 29, 2006

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR25
  • CAN-NCIC-BR25 (Other Identifier: PDQ)
  • CDR0000486919 (Other Identifier: PDQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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