BENITIONSClinical Trial Intelligence

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 질환Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Carcinoma
임상 단계2상
스폰서ECOG-ACRIN Cancer Research Group
상태진행 중(모집 완료)
참여자 수67 명
중재(약물)Capecitabine, Carboplatin, Cisplatin, Etoposide, Laboratory Biomarker Analysis
시작일2015년 11월 6일
완료일2025년 4월 23일
결과 공개일2026년 4월 8일

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
Arm B (Cisplatin, Carboplatin, Etoposide)5.5 months
p-value0.3

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