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

Sponsored by:	National Cancer Institute of Canada
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00346320

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	Procedure: 3-dimensional conformal radiation therapy Procedure: hypofractionated radiation therapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	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)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Local tumor control rate at 2 years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Disease recurrence rates [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Changes in pulmonary function [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	April 2006
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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
- Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 5 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
No concurrent intensity-modulated radiotherapy or tomotherapy

Contacts and Locations

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

Locations

Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Program at Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, Canada, P7B 6V4
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Canada, Quebec
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6

Sponsors and Collaborators

National Cancer Institute of Canada

Investigators

Study Chair:	Patrick C. F. Cheung, MD, FRCPC	Edmond Odette Cancer Centre at Sunnybrook
Investigator:	Sergio L. Faria, MD, PhD	Montreal General Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000486919, CAN-NCIC-BR25
Study First Received:	June 28, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00346320
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms

Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009