Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONradiation therapy
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Late toxicity measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter | — |
| Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter | — |
Countries
Belgium, France, Switzerland
Outcome results
None listed