Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
18 Years
N/A
Both
Lung Cancer
Trial Information
Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Principal Investigator
Jeffrey A. Bogart, MD
Investigator Role:
Study Chair
Investigator Affiliation:
State University of New York - Upstate Medical University
Authority:
United States: Federal Government
Study ID:
CDR0000068409
NCT ID:
NCT00009789
Start Date:
December 2000
Completion Date:
June 2010
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Fairview University Medical Center - University Campus | Minneapolis, Minnesota 55455 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
| Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island, Nebraska 68803 |
| Great Plains Regional Medical Center | North Platte, Nebraska 69101-6598 |
| Oswego Hospital | Oswego, New York 13126 |
| Saint Luke's Hospital | Chesterfield, Missouri 63017 |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
| St. Joseph's Hospital Health Center - Syracuse | Syracuse, New York 13203 |
