EO-ADJUVANT RADIOTHERAPY-CHEMOTHERAPY IN STOMACH CANCER Induction therapy with carboplatin, paclitaxel and radiotherapy in patients with locally advanced gastric cancer - The NARCIS study

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 53 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•T4 tumors (extension into the esophagus is acceptable as long as the bulk (>50%) of the tumor is in the stomach), and/or N2 nodes > 7 suspected nodes on EUS or CT scan, and/or one large lymph node (mass or conglomerate), and/or > 3 suspected lymph nodes in truncus / para-aortal / spleen hilus. All lymphnodes have to be in cranial position of the renal arteries (in other words tumors that are not suitable for participation in the CRITICS (M06CRI) study)
•* stage Ib-IVa (no distant metastases) gastric cancer (histologically confirmed); tumor bulk has to in the stomach but may involve the gastro-esophageal junction
•WHO <= 2
•* age 18-70
•* gastric cancer should be operable according to one of the coordinating surgeons
•* tumornegative laparoscopy
•* no prior RT abdomen and/or chemotherapy
•Hematology: Hb>6.5 mmol/l; leukocytes>3.5x109/l, neutrophils > 1.5x109/l, thrombocytes > 100 x 109/l
•Renal function: serum creatinine <= 1.25 ULN and creatinine clearance > 60 ml/min (measured, or calculated by Cockcroft and Gault formula)
•Liver function: total bilirubin <1.5x ULN, Alk.phosph. and ASAT/ALAT <= 3x ULN
•Registration within 20 working days after gastroscopy
•Start treatment within 10 working days after registration
•Written informed consent

•Distant metastasis; i.e. lymph node metastasis that are encompassed in the radiation portals are acceptable
•Suspected lymph nodes below the renal arteries
•Inoperable patients; due to technical surgery-related aspects or general condition (ASA III or IV)
•Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri. In case of other malignancies, the patients has to be disease-free for * 5 years to be eligible
•Previous radiotherapy involving the planned treatment field or compromising bone marrow reserve
•Previous chemotherapy except adjuvant chemotherapy for e.g. breast or coloncarcinoma, if * 5 years before
•Uncontrolled (bacterial) infections
•Significant non-malignant disease which in the opinion of the study coordinators is incompatible with the protocol
•Neurotoxicity > CTC grade 1
•Pregnancy or breast feeding

发起方

Antoni van Leeuwenhoek Ziekenhuis