Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00009789

Purpose

RATIONALE: Specialized 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: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.

Condition	Intervention	Phase
Lung Cancer	Radiation: accelerated conformational radiotherapy	Phase I

Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment Primary Purpose: Treatment
Official Title:	Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Enrollment:	40
Study Start Date:	December 2000
Study Completion Date:	June 2010
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 29 treatments	Radiation: accelerated conformational radiotherapy
Experimental: 26 Treatments	Radiation: accelerated conformational radiotherapy
Experimental: 23 Treatments	Radiation: accelerated conformational radiotherapy
Experimental: 20 Treatments	Radiation: accelerated conformational radiotherapy
Experimental: 17 Treatments	Radiation: accelerated conformational radiotherapy

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction.
Determine the short-term and long-term toxicity of this regimen in these patients.
Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen.
Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.

Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.

Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 8-32 patients will be accrued for this study within 2-3 years.

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 stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
- Squamous cell carcinoma
- Basaloid carcinoma
- Adenocarcinoma
- Bronchoalveolar carcinoma
- Adenosquamous carcinoma
- Large cell carcinoma
- Large cell neuroendocrine carcinoma
- Giant cell carcinoma
- Sarcomatoid carcinoma
- Non-small cell carcinoma not otherwise specified
Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)
No metastatic disease or hilar or mediastinal lymphadenopathy
- Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
  - No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum
Poor surgical risk, as defined by 1 of the following:
- High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy
- Pulmonary dysfunction indicated by one or more of the following:
  - FEV_1 less than 40% of predicted
  - DLCO less than 50% of predicted
  - Oxygen dependent
  - Chronic PaCO_2 greater than 45 mm Hg
  - VO_2 less than 15 mL/kg/min

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

0-2

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

See Disease Characteristics

Renal:

See Disease Characteristics

Cardiovascular:

See Disease Characteristics

Pulmonary:

See Disease Characteristics

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No weight loss of more than 10% within the past 6 months
No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for NSCLC

Endocrine therapy:

Not specified

Radiotherapy:

No prior chest radiotherapy

Surgery:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009789

Locations

United States, Florida
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Minnesota
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Luke's Hospital
Chesterfield, Missouri, United States, 63017
United States, Nebraska
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, United States, 68803
Great Plains Regional Medical Center
North Platte, Nebraska, United States, 69103
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Oswego Hospital
Oswego, New York, United States, 13126
St. Joseph's Hospital Health Center - Syracuse
Syracuse, New York, United States, 13203
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13057
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Jeffrey A. Bogart, MD

State University of New York - Upstate Medical University

More Information

Additional Information:

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

Publications:

Bogart JA, Hodgson L, Seagren SL, Blackstock AW, Wang X, Lenox R, Turrisi AT 3rd, Reilly J, Gajra A, Vokes EE, Green MR. Phase I Study of Accelerated Conformal Radiotherapy for Stage I Non-Small-Cell Lung Cancer in Patients With Pulmonary Dysfunction: CALGB 39904. J Clin Oncol. 2009 Nov 23; [Epub ahead of print]

Bogart J, Watson D, Seagren S, et al.: Accelerated conformal radiotherapy for stage I non-small cell lung cancer (NSCLC) in patients with pulmonary dysfunction: a CALGB phase I study. [Abstract] J Clin Oncol 25 (Suppl 18): A-7556, 398s, 2007.

Responsible Party:	Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00009789 History of Changes
Other Study ID Numbers:	CDR0000068409, U10CA076001, CALGB-39904
Study First Received:	February 2, 2001
Last Updated:	March 17, 2011
Health Authority:	United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:

stage I non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer

adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 12, 2012