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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000415703 | Registry Identifier | PDQ (Physician Data Query) |
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RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| irinotecan hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Response |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | ||
| Progression-free survival |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
Newly diagnosed, treatment-naive disease
At least 1 unidimensionally measurable lesion
No massive pleural or pericardial effusion by chest CT scan
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No prior radiotherapy to the chest
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Tadashi Mio, MD | Kyoto University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gunma Cancer Center | Gunma | Gunma | 373-8550 | Japan | ||
| National Hospital Organization - Dohoku National Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22430871 | Result | Okishio K, Mio T, Kawahara M, Yoshioka H, Yanagihara K, Daimon T, Furuse K. A weekly combination of carboplatin and irinotecan for previously untreated extensive disease small-cell lung cancer, results of a minimum follow-up of 3 years: a multi-center Phase II trial JMTO LC02-02. Jpn J Clin Oncol. 2012 May;42(5):387-93. doi: 10.1093/jjco/hys028. Epub 2012 Mar 19. |
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| Asahikawa |
| Hokkaido |
| 070-0901 |
| Japan |
| Fujisawa City Hospital | Fujisawa | Kanagawa | 251-8550 | Japan |
| Kurashiki Central Hospital | Kurashiki-shi | Okayama-ken | 710-8602 | Japan |
| Osaka Kosei Nenkin Hospital | Osaka | Osaka | 553-0003 | Japan |
| Osaka General Medical Center | Osaka | Osaka | 558-0056 | Japan |
| National Hospital Organization - Osaka National Hospital | Sakai | Osaka | 591-8555 | Japan |
| Takatsuki Red Cross Hospital | Takatsuki | Osaka | 569-1096 | Japan |
| Yao Tokusyu-kai General Hospital | Yao | Osaka | 561-0072 | Japan |
| Tokyo Medical and Dental University | Tokyo | Tokyo | 113-8519 | Japan |
| National Hospital Organization - Medical Center of Kure | Hiroshima | 737-0023 | Japan |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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