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Tracking Information | |||||
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First Received Date † | June 5, 2003 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date † | April 2003 | ||||
Current 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 ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00062335 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
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 | ||||
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. |
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Detailed Description | OBJECTIVES:
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%).
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. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Lung Cancer | ||||
Intervention † | Radiation: radiation therapy | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Belgium, France, Switzerland | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00062335 | ||||
Responsible Party | |||||
Secondary IDs †† | EORTC-22994 | ||||
Study Sponsor † | European Organization for Research and Treatment of Cancer | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | January 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |