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| ID | Type | Description | Link |
|---|---|---|---|
| YONSEI-4-2007-0120 |
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RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive dose-dense induction chemotherapy comprising irinotecan hydrochloride IV and cisplatin IV on days 1 and 8. Treatment repeats every 21 days for up to 2 courses.
After completion of induction chemotherapy, patients undergo radiotherapy five days a week for approximately 7 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and 29-33.
After completion of study therapy, patients are followed at 6 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| etoposide | Drug | |||
| irinotecan hydrochloride | Drug | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of local/regional control | ||
| Rate of systemic disease control | ||
| Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0 | ||
| Progression-free survival | ||
| Overall survival |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Stage IIIA (N2) or IIIB disease
At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors
Unresectable disease
No known brain metastasis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Joo-Hang Kim, MD | Yonsei University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cancer Center at Yonsei University Medical Center | Recruiting | Seoul | 120-752 | South Korea |
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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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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005047 | Etoposide |
| D000077146 | Irinotecan |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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