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Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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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 CenterChicago, Illinois  60637
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Fairview University Medical Center - University CampusMinneapolis, Minnesota  55455
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health CenterGrand Island, Nebraska  68803
Great Plains Regional Medical CenterNorth Platte, Nebraska  69101-6598
Oswego HospitalOswego, New York  13126
Saint Luke's HospitalChesterfield, Missouri  63017
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
St. Joseph's Hospital Health Center - SyracuseSyracuse, New York  13203