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

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase

Terminated

Phase 1

Conditions

Lung Cancer

Treatments

Radiation: radiation therapy

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00062335

EORTC-22994

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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