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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00062335
• Other study ID #: EORTC-22994
• Secondary ID: EORTC-22994
• Status: Terminated
• Phase: Phase 1
• First received: June 5, 2003
• Last updated: September 20, 2012
• Start date: April 2003

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	Akademisch Ziekenhuis Gent	Ghent
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Institut Curie - Section Medicale	Paris
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy			Yes
Secondary	Late toxicity measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter			Yes
Secondary	Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter			No