A PHASE I TRIAL OF DOSE ESCALATION OF EXTERNAL BEAM RADIATION THERAPY USING CONFORMAL 3-DIMENSIONAL TREATMENT PLANNING FOR NON-SMALL CELL LUNG CANCER
18 Years
N/A
Both
Lung Cancer
Trial Information
A PHASE I TRIAL OF DOSE ESCALATION OF EXTERNAL BEAM RADIATION THERAPY USING CONFORMAL 3-DIMENSIONAL TREATMENT PLANNING FOR NON-SMALL CELL LUNG CANCER
OBJECTIVES:
- Determine the maximum dose of external beam irradiation deliverable using conformal
3-dimensional treatment planning in patients with non-small cell lung cancer.
- Determine the feasibility and efficacy of 3-dimensional treatment planning in
delivering high doses of external beam radiotherapy to these patients.
- Determine whether computer-generated dose-volume histograms and normal tissue
complication probability models can predict the degree of pulmonary toxicity resulting
from external beam radiotherapy.
- Determine the relationship between dose of external beam radiotherapy and the degree of
pulmonary function change.
OUTLINE: This is a dose escalation study.
Patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10
weeks.
Cohorts of 10 patients receive escalating doses of radiotherapy until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which no more than 20% of
patients experience dose-limiting toxicity.
Patients are followed at 1 month and then every 4 months thereafter.
PROJECTED ACCRUAL: A total of 60-70 patients will be accrued for this study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Clinical stage T1-4, N0-2, M0
- Clinical stage T1-2, N0-1 must be medically inoperable
- No distant metastases on history and physical exam, CBC, screening profile, CT or MRI
of brain, CT of chest and abdomen (including adrenals and liver), and bone scan
- No pleural effusions
- Atelectasis not clearly distinguishable from tumor mass allowed provided all tumor
and atelectasis together represent a volume that can be safely treated to the total
dose delivered to gross disease
- Diffuse pulmonary infiltrates thought to represent benign disease allowed only if
representative lesion samples are proven by biopsy or cytology not to contain cancer
- No diffuse bronchoalveolar carcinoma
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancy within the past 5 years except nonmelanomatous skin cancer or
noninvasive cervical carcinoma
- No other medical illness that cannot be adequately controlled with appropriate
therapy or that is considered severe enough to preclude a radical treatment approach
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for lung cancer
Chemotherapy
- No prior chemotherapy for lung cancer
Endocrine therapy
- No prior endocrine therapy for lung cancer
Radiotherapy
- No prior radiotherapy for lung cancer
Surgery
- No prior surgery for lung cancer
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Kenneth Rosenzweig, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000077300
NCT ID:
NCT00002484
Start Date:
October 1991
Completion Date:
Related Keywords:
- Lung Cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
