A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer
N/A
N/A
Both
Lung Cancer
Trial Information
A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer
OBJECTIVES:
- Determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in
patients with inoperable stage I, II, or IIIA non-small cell lung cancer who are
treated according to the total lung volume irradiated.
- Determine the feasibility of this regimen, in terms of local control rates and
incidence of distant metastases, in these patients.
OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Patients
are assigned to 1 of 3 strata according to the total lung volume irradiated (less than 25%
vs 25-37% vs over 37%).
- Stratum I: Patients undergo high-dose 3-dimensional (3-D) conformal radiotherapy 5 days
a week for 6 weeks.
- Stratum II: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for
5.5-7 weeks.
- Stratum III: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for
5.5-6.5 weeks.
Cohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose
3-D conformal radiotherapy (either by increasing the total dose or by shortening treatment
time) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
at which 2 of 6, 2 of 15, or 3 of 30 patients experience dose-limiting toxicity.
Patients are followed at 1 month, at least every 2 months for 1 year, every 3 months for 1
year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 54-135 patients (18-45 per stratum) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Medically inoperable stage I or II disease
- Stage III disease eligible provided the following are true:
- No supraclavicular node involvement
- No peripherally located lower lobe tumor AND contralateral upper
mediastinal node involvement
- No distant metastasis
- No malignant pleural or pericardial effusion
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No prior myocardial infarction
- No prior complete bundle branch block
- No other prior cardiovascular disease resulting in New York Heart Association class
III or IV heart disease
- No clinically significant cardiac arrhythmias
- No congestive heart failure
Pulmonary
- FEV_1 at least 1.2 L OR
- DLCO at least 60%
Other
- No other prior or concurrent malignancy except cured basal cell skin cancer or
carcinoma in situ of the cervix
- No intractable or uncontrolled infection
- No psychological, familial, social, or geographical condition that would preclude
study compliance and follow-up
- Able to tolerate a course of radiotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 3 weeks since prior chemotherapy
- No prior anthracyclines
- No concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the chest area
Surgery
- No prior therapeutic surgery to the chest area
Other
- No other prior therapy to the chest area
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy
Safety Issue:
Yes
Principal Investigator
Jacques Bernier, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Authority:
United States: Federal Government
Study ID:
EORTC-22994
NCT ID:
NCT00062335
Start Date:
April 2003
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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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