Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	Not specified	Other	EORTC-22994 NCT00062335

Objectives

1. 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.
2. Determine the feasibility of this regimen, in terms of local control rates and incidence of distant metastases, in these patients.

Entry 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

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

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

• FEV₁ 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

Expected Enrollment

A total of 54-135 patients (18-45 per stratum) will be accrued for this study.

Outcomes

Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy

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

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Jacques Bernier, MD, PhD, Study coordinator(Contact information may not be current)		Ph: 41-91-811-8666

Registry Information
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
Trial Start Date		2003-04-29
Registered in ClinicalTrials.gov		NCT00062335
Date Submitted to PDQ		2003-05-06
Information Last Verified		2006-01-05

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