EUCTR2010-020606-15-ES进行中（未招募）不适用
An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced or metastatic esophageal squamous cell cancer - POWER
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •1.Signed written informed consent
- •2.Male or female ?18 years of age
- •3.Histologically proven squamous cell carcinoma of the esophagus, which is not curatively respectable* and not eligible for definitive radiochemotherapy**. Patients with locally recurrent disease or clearly metastatic disease (Tx, Nx, M1, locally unresectable T4, Nx, M0 or TX, N3, M0) or macroscopically residual (post-resection) disease not eligible for definitive radiochemotherapy may be enrolled.
- •*resectability has to be defined prior to randomization according to local standards:
- •The tumor is considered unresectable due to:
- •T-stage, N-stage, performance status/nutritional status, co-morbidity (pulmonary function, other), tumor location upper third of the esophagus, relation to other organs/structures), patient refusal, other reasons.
- •**eligibility to definitive radiochemotherapy will be determined according to local standards based on the extent of disease, performance status/nutritional status, co-morbidity (pulmonary function, other), volume of neighboring organs within the radiation field, patient refusal, other reasons.
- •4.Measurable or non-measurable disease according to RECIST 1.1
- •5.ECOG 0-1
- •6.Women of child-bearing potential must have a negative pregnancy test
- •7.Laboratory requirements
- •?Hematology:
- •oAbsolute neutrophil count ?1.5x109/L
- •oPlatelet count ?100x109/L
- •oLeukocyte count > 3.0x109/L
- •oHemoglobin ? 9 g/dL or 5.59 mmol/l
- •?Hepatic Function:
- •oTotal bilirubin ? 1.5 time the upper normal limit (UNL)
- •oAST ? 2.5xUNL in absence of liver metastases, or ?5xUNL in presence of liver metastases
- •oALT ? 2.5xUNL in absence of liver metastases, or ?5xUNL in presence of liver metastases
- •?Renal Function:
- •oCreatinine clearance ?50 mL/min according to Cockroft-Gault formula
- •?Metabolic Function
- •oMagnesium ? lower limit of normal
- •oCalcium ? lower limit of normal
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1.Previous chemotherapy of esophageal cancer except for neoadjuvant treatment without recurrence within 6 months after the end of treatment.
- •2.Concurrent radiotherapy involving target lesions used for this study. Concurrent palliative radiation for non-target lesions is allowed if other lesions are available outside the involved field. Previous pre-operative or post-operative radiotherapy is allowed.
- •3.Previous exposure to EGFR-targeted therapy
- •4.Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix or other curatively treated malignant disease without recurrence after at least 5 years of follow-up
- •5.Known brain metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
- •6.Serious concomitant disease or medical condition that in the judgment of the investigator renders the subject at high risk of treatment complication or reduces the probability of assessing clinical effect.
- •7.Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ? 1 year before enrolment
- •8.Inadequate pulmonary function according to the Investigator?s judgment, history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •9.Hearing loss > NCI-CTC V.4.0.3 Grade 3
- •10.Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •11.Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
- •12.Contraindications to receive any platin, 5-FU or panitumumab
- •13.Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to treatment start
- •14.Known drug abuse/alcohol abuse
- •15.peripheral polyneuropathy > NCI-CTC V 4.03 Grade 2
- •16.chronic inflammatory bowels diseases
- •17.Social situations limiting the compliance with the study requirements
研究者
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