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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 is ongoing, but not recruiting participants.
Study NCT00062335   Information provided by National Cancer Institute (NCI)
First Received: June 5, 2003   Last Updated: February 6, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

June 5, 2003
February 6, 2009
April 2003
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 ]
Same as current
Complete list of historical versions of study NCT00062335 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
 
High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
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

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.

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.

Phase I
Interventional
Treatment, Open Label
Lung Cancer
Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
 
No
 
Belgium,   France,   Switzerland
 
 
NCT00062335
 
EORTC-22994
European Organization for Research and Treatment of Cancer
 
Investigator: Jacques Bernier, MD, PhD Oncology Institute of Southern Switzerland
National Cancer Institute (NCI)
January 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.