eoadjuvant Radiochemotherapy Combined with Panitumumab in Locally Advanced KRAS wild-type Rectal Cancer - NeoRec-1

niversity Hospital Heidelberg0 个研究点目标入组 48 人开始时间: 2010年11月18日最近更新: 2024年9月9日

适应症

试验速览

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•oHistologically confirmed, potentially resectable rectal adenocarcinoma staged as uT3/4 N0/1 by endosonography or cT3/4 by MRI of the pelvis with or without local lymph node metastases.
•oWild-type KRAS.
•oECOG-performance status 0 or 1.
•oAge = 18 years.
•oLaboratory requirements:
•-Haematology: Leucocyte count > 3,000/mm³, neutrophil count =1.5x109/L, hemoglobin = 8 g/dL, platelet count =100x109/L.
•-Hepatic Function: Total bilirubin = 1.5 time the upper normal limit (UNL), ASAT = 2.5xUNL in absence of liver metastases or = 5xUNL in presence of liver metastases, ALAT = 2.5xUNL in absence of liver metastases or = 5xUNL in presence of liver metastases
•-Renal Function: Creatinine clearance =50 mL/min or serum creatinine =1.5xUNL
•-Metabolic Function: Magnesium = lower limit of normal, Calcium = lower limit of normal.
•oNegative ß-HCG-serum pregnancy test (females of child bearing potential).
•oWilling to use double-barrier contraception during study and for 6 months after the end of treatment.
•oAbility of patient to understand character and individual consequences of clinical trial
•oWritten informed consent (must be available before enrolment in the trial)
•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 48
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•oPrior EGFR targeting or prior chemo- or radiotherapy or tumor surgery.
•oEvidence of any distant metastases.
•oManifest or previous secondary malignancies within the last 5 years.
•oUncontrolled infection.
•oClinically significant cardiovascular disease NYHA classification III or IV (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ? 1 year before enrolment/randomization.
•oHistory of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on screening chest CT scan.
•oDiabetes mellitus
•oSubject pregnant or breast feeding, or planning to become pregnant within 6 month after the end of treatment.
•oSubject (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.
•oActive serious illness which renders the patient unsuitable for study entrance, multiple blood sampling or the above mentioned biopsies.
•oHistory of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
•oParticipation in other clinical trials or observation period of competing trials, respectively.

发起方

niversity Hospital Heidelberg