- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00009789
Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Fort Lauderdale, Florida, United States, 33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
-
Hollywood, Florida, United States, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jupiter, Florida, United States, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
-
-
Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Fairview University Medical Center - University Campus
-
-
Missouri
-
Chesterfield, Missouri, United States, 63017
- Saint Luke's Hospital
-
-
Nebraska
-
Grand Island, Nebraska, United States, 68803
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
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North Platte, Nebraska, United States, 69103
- Great Plains Regional Medical Center
-
Omaha, Nebraska, United States, 68198
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
-
-
New York
-
Buffalo, New York, United States, 14215
- Veterans Affairs Medical Center - Buffalo
-
Oswego, New York, United States, 13126
- Oswego Hospital
-
Syracuse, New York, United States, 13210
- SUNY Upstate Medical University Hospital
-
Syracuse, New York, United States, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
-
Syracuse, New York, United States, 13203
- St. Joseph's Hospital Health Center - Syracuse
-
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Blumenthal Cancer Center at Carolinas Medical Center
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Goldsboro, North Carolina, United States, 27534
- Wayne Memorial Hospital, Incorporated
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Winston-Salem, North Carolina, United States, 27157
- Comprehensive Cancer Center at Wake Forest University
-
-
Ohio
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Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224-1791
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
Chemotherapy:
- No prior chemotherapy for NSCLC
Radiotherapy:
- No prior chest radiotherapy
Study Plan
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
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Up to 5 years
|
Up to 5 years
|
Failure-free survival
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jeffrey Bogart, MD, State University of New York - Upstate Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CALGB-39904
- U10CA076001 (U.S. NIH Grant/Contract)
- CDR0000068409 (Registry Identifier: NCI Physician Data Query)
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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