NL-OMON53113招募中2 期
A multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery vs. neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery vs. neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer - CRITICS-II
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 207 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 207
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •TNM 8th ed IB- IIIC gastric cancer (histologically proven); tumour bulk has
- •to be in the stomach but may involve gastro-oesophageal junction
- •Age >= 18 yrs
- •Resectable adenocarcinoma of the stomach or gastro-oesophageal junction
- •No prior abdominal radiotherapy
- •Haematology: Hb >= 5.0 mmol/l; leukocytes >= 3.0x109/l, neutrophils >=
- •1.5x109/l, thrombocytes * >= 100x109/l
- •Renal function: serum creatinine <= 1.25x ULN, creatinine clearance >= 50
- •ml/min (calculated by Cockcroft and Gault formula)
- •Liver function: total bilirubin <= 1.5x ULN, alkaline phosphatase and
- •ASAT/ALAT <= 3x ULN
- •At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal
- •lesions and/or substantial free peritoneal fluid if any should be
- •pathologically proven tumor negative
- •Start treatment within 15 working days after randomisation
- •Written informed consent
- •Expected adequacy of follow-up
- •Caloric intake >= 1500 kcal/day, verified by a dietician before registration.
- •-- if caloric intake is < 1500 kcal/day or if bodyweight has decreased
- •> 10% over the last 6 months or > 5% over the last month, dietary intervention
- •such as oral nutritional support or enteral tube feeding is mandatory
排除标准
- •T1N0 disease endoscopic ultrasound
- •Distant metastases
- •Irresectable patients; due to technical surgery-related factors or general
- •Previous malignancy, except adequately treated non-melanoma skin cancer or
- •in-situ cancer of the cervix uteri; in case of a previous other malignancy with
- •a disease-free period >= 5 years, inclusion can be accepted after consultation
- •of the principal investigator
- •Solitary functioning kidney that will be within the radiation field
- •Major surgery within 4 weeks prior to study treatment start, or lack of
- •complete recovery from the effects of major surgery
- •Uncontrolled (bacterial) infections
- •Significant concomitant diseases preventing the safe administration of study
- •drugs or likely to interfere with study assessments
- •Uncontrolled angina pectoris, cardiac failure or clinically significant
- •arrhythmias
- •Continuous use of immunosuppressive agents equivalent to >10 mg daily
- •Concurrent use of the antiviral agent sorivudine or chemically related
- •analogues, such as brivudine
- •Neurotoxicity > CTC grade 1
- •Pregnancy or breast feeding
- •Patients (M/F) with reproductive potential not implementing adequate
- •contraceptive measures
- •Gastric or gastro-esophageal stent within radiation field
研究者
相似试验
进行中（未招募）
1 期
A randomised trial for gastric cancer with neo-adjuvant chemotherapy, chemoradiotherapy and surgeryEUCTR2015-004627-31-NLThe Netherlands Cancer Institute
进行中（未招募）
1 期
Pre-operative chemotherapy associated or not with zoledronate and atorvastatin in patients with triple negative breast cancer - YAPPETIZER StudyTriple Negative Breast CancerMedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-005112-17-ITIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI154
进行中（未招募）
1 期
Phase II study, open label, single arm, evaluating the efficacy of neoadjuvant eribulin mesylate in patients with triple negative breast cancerEUCTR2012-004956-12-ITISTITUTO NAZIONALE PER LA CURA TUMORI48
招募中
2 期
A study of neoadjuvant PEMbrolizumab before radical PROstatectomy (PEM-PRO) in patients affected by high-risk prostate cancer2024-514580-26-00Ospedale San Raffaele S.r.l.59
进行中（未招募）
1 期
Randomized trial in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer in the presurgical setting to test whether the addition of GDC-0032 to letrozole gives added benefitWOMEN WITH ER-POSITIVE/HER2-NEGATIVE, EARLY STAGE BREAST CANCERMedDRA version: 18.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864EUCTR2013-000568-28-BEGenentech, Inc.330