VECTIBIX PLUS OXALIPLATIN-BASED ADJUVANT TREATMENT OF RECTAL CANCER - VECTOX

Anticancer Informing Me Gnosi Nika0 个研究点开始时间: 2010年10月6日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•All the following must be met
•Written Informed consent
•Adult patients with resected rectal cancer, stage 2 and 3
•Wild-type kRAS tumor status
•Adequate PS <2
•Resection of rectal cancer preceded by chemo-irradiation; there should be at least 3 weeks of postoperative recovery allowed before initiation of adjuvant treatment. If patients have not received preoperative chemoradiation, it should be administered postoperatively upon recovery from surgery. Enrollment in the protocol will take place following chemoirradiation (2-4 weeks after the last radiation administration).
•Laboratory Values
•Haematology:
•Neutrophil count =1.5x109/L
•Platelet count =100x109/L
•Leucocytes count > 3,000/mm3
•Hemoglobin > 9mg/dL
•Hepatic Function:
•Total bilirubin = 1.5 time the upper normal limit (UNL)
•AST (SGOT) = 2.5xUNL
•ALT (SGPT) = 2.5xUNL
•Renal Function
•Creatinine clearance =50 mL/min
•Metabolic Function
•- Magnesium = lower limit of normal.
•- Calcium = 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment/randomization
•History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
•Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
•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.
•Any significant co-morbidity precluding administration of adjuvant chemotherapy
•Patients who have previously received Vectibix or Cetuximab

发起方

Anticancer Informing Me Gnosi Nika