EUCTR2016-002576-27-FR进行中（未招募）1 期
ean body mass normalization of oxaliplatin based chemotherapy for stage III colon cancer patients treated in adjuvant satting: Impact on Oxaliplatin induced sensitive neurotoxicity. A multicenter phase II randomized trial - LEANOX
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 308
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: more than 18 years old up to 75 years old including. Histologically confirmed adenocarcinoma of the colon.
- •-Has undergone a curative resection for stage III colon cancer.
- •-Scheduled to receive 6 months of Oxaliplatin-based adjuvant chemotherapy at a dose of 85 mg/m² of Oxaliplatin every 2 weeks (simplified FOLFOX 4 regimen).
- •-The following laboratory values obtained = 28 days prior to inclusion:
- •WBC = 3000/mm3; ANC =1500/mm3; PLT =100,000/mm3; HgB =10.0g/dl; Total bilirubin =1.5 x upper normal limit (UNL); Serum creatinine =1.5 x UNL; Serum calcium = 1.2 x UNL; Serum magnesium = 1.2 x UNL.
- •-Central venous access line present or patient scheduled to have a central line placed prior to starting chemotherapy or the treatment protocol.
- •-Negative pregnancy test (serum or urine) done = 7 days prior to registration, for women of childbearing potential only.
- •-Ability to complete questionnaire(s) by themselves or with assistance.
- •-ECOG Performance Status (PS) of 0, 1 for patients until 70 years old included and ECOG PS of 0 for patients between 70 to 75 years old included.
- •-Has provided informed written consent.
- •-Patient willing to provide blood sample for research purposes
- •-Patient affiliated to a French social security system
- •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 308
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 308
排除标准
- •-Pregnant or breastfeeding women
- •-Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
- •-Pre-existing peripheral neuropathy of any grade.
- •-Prior treatment with neurotoxic chemotherapy such as Oxaliplatin, cisplatin, taxanes, or vinca alkaloids.
- •-Treatment with 1) the anticonvulsants carbamazepine (e.g., Tegretol®), phenytoin (e.g., Dilantin®), valproic acid (e.g. Depakine®), gabapentin (Neurontin®); pregabalin (Lyrica®); 2) the following neurotropic agents: venlafaxine (Effexor®), desvenlafaxine (Pristiq®), milnacipran (Savella®) or duloxetine (Cymbalta®); 3) Tricyclic antidepressants (such as amitryptilline) or 4) any other agent specifically given to prevent or treat neuropathy.
- •-Family history of a genetic/familial neuropathy.
- •-Participation in another medication trial within 30 days prior to study entry
- •-Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to terminate the study
- •-History of other solid tumor in 3 years before the inclusion, excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.
研究者
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