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| ID | Type | Description | Link |
|---|---|---|---|
| ICORG-99-09 | |||
| EU-20922 |
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RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor over a shorter period of time may kill more tumor cells and cause less damage to normal tissue.
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to combined lung volume at 25 Gy (≤ 30% vs > 30%). Patients are assigned to 1 of 3 treatment groups.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 Gy). |
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| Group 2 | Experimental | Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 Gy). |
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| Group 3 | Experimental | Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 Gy). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypofractionated radiation therapy | Radiation | Given 5 days a week for 20, 22, or 24 fractions |
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| Measure | Description | Time Frame |
|---|---|---|
| Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy | weekly during radiotherapy | |
| Long-term radio-induced toxicity as assessed by the long-term RTOG/EORTC and SWOG (lung) grading system every 3 months for 2 years and then every 6 months thereafter | every 3 months for 2 years and then every 6 months thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rate (according to WHO response criteria) as assessed by CT scan at 3 months after completion of radiotherapy | at 3 months after completion of radiotherapy | |
| Actuarial freedom from thoracic progression rate | ongoing |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer meeting 1 of the following stage criteria:
Stage I or II disease
Stage IIIA or IIIB disease (no pleural effusions)
Radiation dose parameters must satisfy the required study dose-volume constraints
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Thirion, MD | Saint Luke's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Luke's Hospital | Dublin | 6 | Ireland |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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