Lung Cancer Clinical Trial
Official title:
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
RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan
treatment may enable doctors to provide more effective radiation therapy that will cause
less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of high-dose
3-dimensional conformal radiation therapy in treating patients with inoperable stage I,
stage II, or stage IIIA 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.
;
Masking: Open Label, Primary Purpose: Treatment
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