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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jules Bordet
  • Academisch Ziekenhuis der Vrije Universiteit Brussel
  • Akademisch Ziekenhuis Gent
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Antoine Lacassagne
  • Institut Curie - Section Medicale
  • Centre Hospitalier Universitaire Vaudois

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 5, 2003
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00062335
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
April 2003 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy
Secondary Outcome Measure Information:
Title
Late toxicity measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter
Title
Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Bernier, MD, PhD
Organizational Affiliation
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Academisch Ziekenhuis der Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Akademisch Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Curie - Section Medicale
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland

12. IPD Sharing Statement

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

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