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临床试验/EUCTR2010-020606-15-DE
EUCTR2010-020606-15-DE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

AIO-Studien-gGmbH0 个研究点目标入组 300 人开始时间: 2011年12月2日最近更新:
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适应症
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
300
研究概览入排标准研究者记录与标识符相似试验

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
  • •resectable* 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:
  • •o Total bilirubin = 1.5 time the upper normal limit (UNL)
  • •o AST = 2.5xUNL in absence of liver metastases, or =5xUNL in presence of liver
  • •o ALT = 2.5xUNL in absence of liver metastases, or =5xUNL in presence of liver
  • •· Renal Function:
  • •o Creatinine clearance =50 mL/min according to Cockroft-Gault formula
  • •· Metabolic Function
  • •o Magnesium = 0.5 mmol/L or 1.2 mg/dL
  • •o Calcium = 2 mmol/L or 8.0 mg/dL
  • •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 210
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 90

排除标准

  • •1. Previous chemotherapy of esophageal cancer in the metastatic setting. Previous
  • •neoadjuvant chemotherapy or definitive radiochemotherapy with a maximum
  • •cumulative dose of 120 mg cisplatin and without recurrence of disease within 4
  • •months after the end of treatment is allowed.
  • •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
  • •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
  • •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.4.03 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. Current drug abuse/alcohol abuse interfering with compliance with the study
  • •requirements
  • •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.
  • •18. History of HIV infection or chronic hepatitis B or C
  • •19. Concurrent treatment with brivudin or sorivudin or its chemically related analogues.
  • •There must be at least a 4-week wash-out period between end of treatment with
  • •brivudin, sorivudin or its chemically related analogues and start of therapy with 5-FU.

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