EUCTR2004-005135-26-DE进行中（未招募）1 期
ORAL VINORELBINE AND CISPLATIN WITH CONCOMITANT RADIOTHERAPY FOLLOWED BY EITHER CONSOLIDATION THERAPY WITH ORAL VINORELBINE AND CISPLATIN PLUS BEST SUPPORTIVE CARE OR BEST SUPPORTIVE CARE ALONE IN STAGE III NON SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE III STUDY
Pierre Fabre Médicament0 个研究点目标入组 376 人开始时间: 2005年3月22日最近更新:
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
- 376
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
入选标准
- •- Patients aged between 18 and 75 years
- •- Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer (NSCLC)
- •- Untreated locally advanced inoperable stage IIIA (only N2) or Untreated locally advanced inoperable stage IIIB amenable to radical radiotherapy to a dose of 66 Gy
- •- Patients with a Karnofsky Performance Status not less than 80%
- •- Adequate pulmonary function
- •- Life expectancy not less than 12 weeks
- •- Patients without weight loss > 10% within the previous 3 months
- •- Adequate bone marrow, hepatic and renal functions
- •- Presence of at least one measurable lesion (RECIST criteria)
- •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
- •- Patients with NSCLC stage IV
- •- Patients with NSCLC stages I, II, IIIA (except N2)·
- •- Patients with NSCLC stage IIIB: with malignant pleural effusion; with tumour extent or location precluding radical radiotherapy as specified in the protocol·
- •- Symptomatic neuropathy (sensory) > grade 1 according to the NCI Common Toxicity Criteria
- •- Hearing impairment not less than Grade 2
- •- Concomitant/uncontrolled medical disorder (cardiovascular, hepatic or other systemic disease)
- •- Weight loss > 10% within the previous 3 months
- •- Pre-existing malignant pleural effusion
- •- Ascites or pericardial effusion
- •- Active secondary malignancy except appropriately treated carcinoma in situ of the cervix or skin basal cell cancer. Patients with a history of cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible
- •- Previous or concomitant treatment with other anticancer drugs during the last 5 years
- •- Known hypersensitivity to the study drugs or to drugs with similar chemical structures
- •- Concomitant treatment with systemic corticosteroids except chronic treatment lasting more than 1 month at low doses (not less than 20 mg/day of methyl prednisolone or equivalent)
- •- Significant malabsorption syndrome or disease affecting the gastrointestinal tract function
- •- Women if pregnant or breast-feeding or with Positive pregnancy test at inclusion
- •- Male or female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the study treatment
研究者
相似试验
已完成
3 期
Oral Chemotherapy And Platinum With Radiotherapy Followed Or Not By Consolidation With The Same Chemotherapy In Locally Advanced Non Small Cell Lung CancerNSCLCNCT00683514Pierre Fabre Medicament201
进行中（未招募）
1 期
Study to assess the efficacy and safety of oral vinorelbine in combination with capecitabine in patients suffering from breast cancer previously treated with other chemotherapies (anthracyclines, and taxanes)EUCTR2004-000665-35-ESPierre Fabre Medicament
进行中（未招募）
1 期
Phase II trial of oral vinorelbine in combination with capecitabine and trastuzumab as first line therapy in women with previously untreated HER2 positive metastatic breast cancer. - Not applicableEUCTR2004-000748-26-ESPierre Fabre Ibérica, S.A. en representación de Pierre Fabre Mèdicament55
进行中（未招募）
1 期
Phase II trial of oral vinorelbine in combination with capecitabine as first line therapy in women with previously untreated HER2 negative metastatic breast cancer. - Not applicableTreatment in women with previously untreated HER2 negative metastatic breast cancer.EUCTR2004-000753-30-ESPierre Fabre Ibérica S.A. as legal representative of Pierr Fabre Mèdicament55
进行中（未招募）
不适用
VINORELBINE AND CAPECITABINE as first line treatment in advanced breast cancer patients with non measurable lesions for RECIST criteria - VNBCAPmetastatic breast cancerEUCTR2005-005680-29-ITAZIENDA OSPEDALIERA S. LUIGI GONZAGA100