EUCTR2013-001203-36-PT
Active, not recruiting
Not Applicable
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 sitesDecember 13, 2013
ConditionsRectal cancer stage IIRectal cancer stage IIIMedDRA version: 16.1Level: PTClassification code 10038050Term: Rectal cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10038049Term: Rectal cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsTyverb
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal cancer stage IIRectal cancer stage III
- Sponsor
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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 \< 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,
Outcomes
Primary Outcomes
Not specified
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