Phase II trial of the addition of Lapatinib to Capecitabine versus Capecitabine alone as radio-sensitizers in KRAS wild type resectablerectal cancer - LaRRC Trial

Instituto Português de Oncologia do Porto Francisco Gentil, EPE0 个研究点开始时间: 2013年12月13日最近更新: 2014年3月10日

适应症

试验速览

暂无简介。

•1. Age 18 years or above.
•2. Diagnosis of adenocarcinoma of the rectum with the primary malignant lesion located between the dentate line up to 10cm of the anal verge by endoscopic examination.
•3. KRAS mutational analysis of codon 12 and 13 without known activating mutations.
•4. Clinical Stage II or III disease, according to AJCC Staging classification, 7th edition. For clinical staging the following procedures must have been conducted, within 4 weeks of treatment allocation:
•4.1. Clinical History and Physical Examination,
•4.2. Endoscopic ultrasound of the primary lesion,
•4.3. Thoracic, abdominal and pelvic computed tomographic scan.
•5. Clinically judged to be able to undergo curative resection of the rectal neoplasm despite pre-operative chemoradiotherapy.
•6. Clinically judged to be able to undergo pelvic radiation therapy to a total dose of 50.4 Gy.
•7. Signed informed consent.
•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 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Absence of baseline histological sample of the primary tumor.
•2. Pregnant or lactating women.
•3. Unwillingness or inability to comply with effective contraception, if the patient is fertile.
•4. Impaired renal function defined as creatinine clearance < 60mL/min according to the Cockcroft-Gault formula.
•5. Impaired hematological function: defined by any of the following on pre-treatment evaluation:
•5.1. Hemoglobin concentration < 10.0 g/dL,
•5.2. Absolute neutrophile count < 1 500 µL-1 and
•5.3. Platelet count < 100 000 µL-1.
•6. Impaired hepatic function defined by any of the following on pre-treatment evaluation:
•6.1. Serum level of aspartate aminotransferase > 1.5 x ULN,
•6.2. Serum level of alanine aminotransferase > 1.5 x ULN,
•6.3. Serum level of alkaline phosphatase > 1.5 x ULN,
•6.4. International Normalized Ratio > 1.5 and
•6.5. Serum concentration of total bilirrubin > 1.5 x ULN.
•7. Symptomatic heart failure or a left ventricular ejection fraction below the institution’s lower limit of normality as assessed through equilibrium radionuclide angiography.
•8. Known intolerance to any of the study drugs.
•9. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
•10. Concurrent treatment with CYP3A4 inducers.
•11. Concurrent treatment with CYP3A4 inhibitors.
•12. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel.
•13. Currently enrolled in another clinical trial.

发起方

Instituto Português de Oncologia do Porto Francisco Gentil, EPE