Rectal cancer stage II Rectal cancer stage III MedDRA version: 16.1 Level: PT Classification code 10038050 Term: Rectal cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: PT Classification code 10038049 Term: Rectal cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Tyverb
Pharmaceutical Form: Film-coated tablet
Sponsors
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial’s objective is to show the superiority of Lapatinib and Capecitabine combination (arm A) over the standard Capecitabine (arm B);Secondary Objective: Not Applicable;Primary end point(s): The primary endpoint is pathologic complete remission. ;Timepoint(s) of evaluation of this end point: After surgical treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety profile of the combination Lapatinib / Capecitabine / Radiation therapy in the pre-operative setting of patients with resectable rectal cancer.;Timepoint(s) of evaluation of this end point: Through-out the length of the trial until the end of study, 28 days after surgery. | — |
Countries
Portugal
Contacts
Public ContactUnidade de Investigação Clínica
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Outcome results
None listed