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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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00062335
First received: June 5, 2003
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Lung Cancer
 Radiation: radiation therapy
 Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy [ Designated as safety issue: Yes ]

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 [ Designated as safety issue: Yes ]
  • Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: April 2003
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062335

Locations
Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, Belgium, 1090
Institut Jules Bordet
Brussels, Belgium, 1000
Akademisch Ziekenhuis Gent
Ghent, Belgium, B-9000
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
Institut Curie - Section Medicale
Paris, France, 75248
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Jacques Bernier, MD, PhD Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00062335     History of Changes
Other Study ID Numbers: EORTC-22994, EORTC-22994
Study First Received: June 5, 2003
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013