BENITIONSClinical Trial Intelligence

Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas

第2相 実施中(募集終了) NCT02595424

対象疾患Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Carcinoma
第2相
スポンサーECOG-ACRIN Cancer Research Group
ステータス実施中(募集終了)
参加者数67 名
介入(薬剤)Capecitabine, Carboplatin, Cisplatin, Etoposide, Laboratory Biomarker Analysis
開始日2015年11月6日
完了日2025年4月23日
結果公開日2026年4月8日

概要

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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