EUCTR2004-004273-28-GB进行中（未招募）不适用
A phase II feasibility trial of induction chemotherapy followed by extrapleural pneumonectomy and postoperative radiotherapy in patients with malignantpleural mesothelioma.
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 52 人开始时间: 2005年8月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
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
- •? Age < 70 years
- •? WHO performance status 0-1 (see Appendix B)
- •? Patient should be considered fit enough to receive chemotherapy, to undergo a
- •pneumonectomy and receive postoperative radiotherapy. The responsible physician,
- •surgeon and radiation therapist should judge the required fitness prior to registration, taking into account the results of all the relevant (i.e. pulmonary, cardiac) examinations.
- •? Pathologically proven malignant pleural mesothelioma (all subtypes accepted)
- •? cT3N1M0 or less according to UICC TNM classification (see Appendix F, Ref. 6)
- •? No N2 or N3 lymph nodes involvement (pathologically confirmed), cervical
- •mediastinoscopy required
- •? No clinical invasion of mediastinal structures (heart, aorta, spine, esophagus, etc.)
- •? No widespread chest wall invasion, only focal chest wall lesions are acceptable
- •? No clinical or radiological evidence of ‘shrinking hemithorax’
- •? No prior chemotherapy for mesothelioma
- •? No prior radiotherapy of the lower neck, thorax, and upper abdomen
- •? No secondary primary malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma).
- •? Adequate hematological, hepatic and renal function
- •? White Blood Cell Count > 3,5 x 109/l
- •? Absolute Neutrophil Count (ANC) > 1,5 x 109/l
- •? Platelet count > 100 x 109/l
- •? Hemoglobin > 11 g/dl
- •? Bilirubin < 1.5 x upper normal limit
- •? ASAT/ALAT < 1.5 x upper normal limit
- •? Alkaline phosphatase < 1.5 x upper normal limit
- •? Creatinine clearance > 60 ml/min
- •? Acceptable (predicted) post-radiotherapy renal function, as indicated by semiquantitative isotope renography, with a relative contribution of the contralateral kidney of at least 40%
- •? No pre-existing sensory neurotoxicity > grade 1 according Common Terminology
- •Criteria for Adverse Events (CTCAE) v3.0 ( http://ctep.cancer.gov/reporting/ctc.html).
- •? No clinically significant third-space fluid (for example pleural effusions or ascites) that cannot be managed with thoracentesis or pleurodesis (according to institutional practice)
- •? No uncontrolled infection
- •? Patients of reproductive potential must agree to use a reliable method of birth control during protocol treatment and for 3 months following the end of protocol treatment. Women of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.
- •? Absence of any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •? Before patient registration in the trial, written informed consent must be obtained
- •and documented according to national and local regulatory requirements and the
- •local rules followed in the institution.
- •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
- 未提供
研究者
相似试验
进行中（未招募）
不适用
Phase II feasibility trial of ijduction chemotherapy followed by extrapleural pneumonectomy and postoperative radiotherapy in patients with malignant pleural mesotheliomamalignant pleural mesotheliomaEUCTR2004-004273-28-ITE.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER52
进行中（未招募）
1 期
Comparison of two treatment arms of patients with non-small cell lung cancer. Patients of one arm receive the authorized infusion Durvalumab after chemotherapy, chemotherapy with radiotherapy and optional resection. Patients in the second treatment arm receive Durvalumab from the beginning, in parallel with standard therapy.non-small cell lung cancer stages IIIA (N2) and selected resectable stages IIIBMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-000058-77-DEniversity Hospital Essen90
招募中
2 期
The novel induction therapy by low-dose cytarabine and blinatumomab for relapse/refractory ACD19-positive B cell precursor acute lymphoblastic leukemiachildren, relapsed, refractory, acute lymphoblastic leukemiaD007938JPRN-jRCTs041210107Goto Hiroaki45
进行中（未招募）
1 期
Randomised Phase II Pilot Studiy: Induction Chemotherapy with Docetaxel, Cisplatin und Cetuximab versus Docetaxel, Cisplatin und 5 FU followed by Radiotherapy with Cetuximab for locally advanced or not resectable Carcinoma of the Head and Neckocally advanced or not resectable Carcinoma of the Head and NeckMedDRA version: 20.0Level: LLTClassification code 10041862Term: Squamous cell carcinoma of the oral cavity stage IIISystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10041863Term: Squamous cell carcinoma of the oral cavity stage IVSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10041855Term: Squamous cell carcinoma of the hypopharynx stage IVSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10023860Term: Laryngeal squamous cell carcinoma stage IIISystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10041854Term: Squamous cell carcinoma of the hypopharynx stage IIISystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10023861Term: Laryngeal squamous cell carcinoma stage IVSystem Organ Class: 100000004864EUCTR2011-005540-99-ATAGMT – Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH100
进行中（未招募）
1 期
Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer (CALIBER)EUCTR2013-005095-18-GBThe Institute of Cancer Research89