A randomised phase II trial comparing the effect of Camptothecin-11 (CPT-11), Fluorouracil (5FU) and Folinic Acid versus CPT-11, 5FU and Folinic Acid followed by Oxaliplatin, 5FU and Folinic Acid on objective response rate in patients with metastatic colorectal cancer

Hellenic Cooperative Oncology Group (HeCOG)0 个研究点目标入组 314 人开始时间: 2009年7月15日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•INCUSION CRITERIA
•Histologically confirmed metastatic adeno-carcinoma of the colon or rectum.
•Measurable metastatic disease (at least one) bidimensionally measurable lesion [according to WHO (World Health Organization) criteria].
•No potentailly resectable metastasis.
•Patients should be over 18 years old.
•WHO/ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
•No prior chemotherapy or only adjuvant chemotherapy ended more than 6 months before randomisation.
•Adequate renal and liver function creatinine <= 1.5 x upper normal limits, Serum glutamic oxaloacetic transaminase (SGOT)/Serum glutamic pyruvic transaminase (SGPT) <=5 x upper normal limits).
•Baseline neutrophil count > 1,500/iL and platelet count > 100,000/iL.

•EXCLUSION CRITERIA
•Pregnant or lactating patients.
•Patients with reproductive potential who are not using adequate contraceptive measures.
•Any prior chemotherapy for advanced disease. Adjuvant treatment ended within 6 months preceding study entry.
•Central Nervous System (CNS) metastases, bone metastases or serosal effusions as the sole indicate of tumour.
•Current history of chronic diarrhea.
•Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
•Other serious illness (recent history of myocardial infarction, < 6 months).

发起方