EUCTR2006-003708-21-BE进行中（未招募）1 期
Concurrent helical tomotherapy with chemotherapy in unresectable stage III non-small cell lung cancer (NSCLC):a phase I/II trial of radiation dose escalation and fixed dose chemotherapy. - TomoCT
AZ-VUB0 个研究点目标入组 30 人开始时间: 2006年10月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Informed consent (A4) is required.
- •Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
- •Patients must have a stage III unresectable LA-NSCLC:
- •Males or females aged between 18 and 75 years.
- •Life expectancy of at least 12 weeks.
- •ECOG performance status 0,1 or2.
- •Weight loss = 10% within the last 3 months.
- •Laboratory requirements at entry:
- •Blood cell counts:
- •i.Absolute neutrophils = 2.0 x 109/L
- •ii.Platelets = 100 x 109/L
- •iii.Haemoglobin = 11 g/dl
- •Renal function:
- •iv.Serum creatinine < 1 x the upper limit of normal (UNL).
- •v.In case of borderline value of serum creatinine, the 24h creatinine clearance should be > 60 ml/min.
- •Hepatic function:
- •vi.Serum bilirubin < 1 x UNL
- •vii.ASAT and ALAT < 2.5 x UNL
- •viii.alkaline phosphatase < 5 x UNL
- •ix.Patient with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase> 2.5 x UNL is not eligible for the study.
- •Lung function tests at entry:
- •FEV1: = 50 % x Normal value
- •DLCO: = 50 % x Normal value
- •Adequate cardiac function.
- •Patient with either measurable and/or non-measurable lesion (according to RECIST criteria, A1).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Diagnosis of small cell lung cancer.
- •Stage IIIB NSCLC, based on the presence of malignant pleural or pericardial effusion.
- •Pregnant or lactating women.
- •Patients (male or female) with reproductive potential not implementing adequate contraceptive measures.
- •Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC.
- •Prior surgery for NSCLC, if less than 5 years from study.
- •Prior radiotherapy for NSCLC.
- •History of prior malignancy, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
- •Symptomatic peripheral neuropathy Grade = 2 except if due to trauma.
- •Other serious concomitant illness or medical conditions:
- •Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias.
- •History of significant neurological or psychiatric disorders including dementia or seizures.
- •Active infection requiring IV antibiotics.
- •Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy.
- •Superior vena cava syndrome contra-indicating hydration.
- •Pre-existing pericardial effusion.
- •Pre-existing symptomatic pleural effusion.
- •Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
- •Distant metastasis.
- •Concurrent treatment with any other experimental anti-cancer drugs.
- •Concomitant or within 4-week period administration of any other experimental drug under investigation.
- •Significant ophthalmologic abnormalities.
- •Moderate to severe dermatitis.
- •Hypersensitivity to docetaxel, cisplatin, or any of its excipients.
- •Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
- •Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- •Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and not likely to complete the study.
研究者
相似试验
Unknown
1 期
Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)Non-Small-Cell Lung CarcinomaNCT00379717AZ-VUB30
进行中（未招募）
2 期
Intensity modulated radiation therapy in Patients with locally advanced inoperable gall bladder and pancreatic cancerCTRI/2016/08/007129Tata Memorial Hospital60
进行中（未招募）
不适用
Tandem high-dose chemotherapy (HDCT) with peripheral-blood stem-cell rescue for patients with metastatic germ-cell tumors failing first-line treatment. - High-dose chemotherapy for relapsed germ-cell cancerPatients with metastatic germ-cell tumors failing first-line treatment.MedDRA version: 9.1Level: LLTClassification code 10043302MedDRA version: 9.1Level: LLTClassification code 10061378EUCTR2010-021898-36-ITISTITUTO NAZIONALE PER LA CURA TUMORI
未知
不适用
Ion beam therapy with concurrent chemotherapy using Gemcitabine for unresectable pancreatic cancer, Phase I/II studypancreatic cancerJPRN-UMIN000002173Department of Radiology, Hyogo Ion Beam Medical Center30
尚未招募
2 期
Combination of chemoTherapy aNd chemoradioTherapy for adenocarcinoma of the OESophagus and gastro-oesophageal junction with limited metastatic disease - TNT-OES-1 TRIAesophageal cancerNL-OMON49762Erasmus MC, Universitair Medisch Centrum Rotterdam20