Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas
2상
진행 중(모집 완료)
NCT02595424
| 대상 질환 | Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Carcinoma |
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| 임상 단계 | 2상 |
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| 스폰서 | ECOG-ACRIN Cancer Research Group |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 67 명 |
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| 중재(약물) | Capecitabine, Carboplatin, Cisplatin, Etoposide, Laboratory Biomarker Analysis |
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| 시작일 | 2015년 11월 6일 |
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| 완료일 | 2025년 4월 23일 |
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| 결과 공개일 | 2026년 4월 8일 |
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요약
This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.
Progression-free Survival (PFS)
assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years from randomization until disease progression, up to 5 years from study registration · months
| Arm A (Capecitabine, Temozolomide) | 3.1 months |
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| Arm B (Cisplatin, Carboplatin, Etoposide) | 5.5 months |
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