Hypofractionated 3-Dimensional Radiation Therapy in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer. ICORG 99-09
NCT ID: NCT00955175
Last Updated: 2016-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2000-11-30
Brief Summary
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PURPOSE: This phase II trial is studying the side effects of hypofractionated 3-dimensional radiation therapy and to see how well it works in treating patients with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.
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Detailed Description
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Primary
* To evaluate the acute and long-term radio-induced toxicity (any organ) of hypofractionated 3-dimensional conformal radiotherapy in patients with newly diagnosed stage I-III non-small cell lung cancer.
Secondary
* To assess the radiological tumor response rate at 3 months after completion of radiotherapy.
* To assess the actuarial freedom from thoracic progression rate.
OUTLINE: Patients are stratified according to combined lung volume at 25 Gy (≤ 30% vs \> 30%). Patients are assigned to 1 of 3 treatment groups.
* Group 1: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 Gy).
* Group 2: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 Gy).
* Group 3: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 Gy).
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 Gy).
hypofractionated radiation therapy
Given 5 days a week for 20, 22, or 24 fractions
Group 2
Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 Gy).
hypofractionated radiation therapy
Given 5 days a week for 20, 22, or 24 fractions
Group 3
Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 Gy).
hypofractionated radiation therapy
Given 5 days a week for 20, 22, or 24 fractions
Interventions
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hypofractionated radiation therapy
Given 5 days a week for 20, 22, or 24 fractions
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer meeting 1 of the following stage criteria:
* Stage I or II disease
* Medically inoperable or patient refused surgery
* Stage IIIA or IIIB disease (no pleural effusions)
* Radiation dose parameters must satisfy the required study dose-volume constraints
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Weight loss ≤ 10% within 3 months before diagnosis
* No other malignancy within the past 5 years, except nonmelanoma skin cancer
* No clinically significant cardiovascular disease (e.g., hypertension \[blood pressure \> 150/100 mm Hg\], myocardial infarction or stroke within the past 6 months, or unstable angina)
PRIOR CONCURRENT THERAPY:
* No concurrent chemotherapy
120 Years
ALL
No
Sponsors
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Cancer Trials Ireland
NETWORK
Responsible Party
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Principal Investigators
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Pierre Thirion, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Luke's Hospital
Locations
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Saint Luke's Hospital
Dublin, , Ireland
Countries
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Other Identifiers
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ICORG-99-09
Identifier Type: -
Identifier Source: secondary_id
EU-20922
Identifier Type: -
Identifier Source: secondary_id
99-09 ICORG
Identifier Type: -
Identifier Source: org_study_id
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