Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Jacques Bernier, MD, PhD

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00062335
Information obtained from ClinicalTrials.gov on December 21, 2011

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