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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00346320
First received: June 28, 2006
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: 3-dimensional conformal radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Local tumor control rate at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Overall tumor control rate will be assessed at 6 years


Secondary Outcome Measures:
  • Toxicity [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Disease recurrence rates [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Changes in pulmonary function [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2006
Study Completion Date: August 2014
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346320

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

Additional Information:
No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00346320     History of Changes
Other Study ID Numbers: BR25, CAN-NCIC-BR25, CDR0000486919
Study First Received: June 28, 2006
Last Updated: August 21, 2014
Health Authority: Canada: NCIC Clinical Trials Group

Keywords provided by NCIC Clinical Trials Group:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014