Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)

Launched by WISP WISSENSCHAFTLICHER SERVICE PHARMA GMBH · Dec 8, 2010

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Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed diagnosis of locally advanced rectal cancer (stage II or III) localised 0 - 12 cm ab ano as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
• • Staging requirements: trans-rectal endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI)
• • Sufficient representative sample material for RAS analysis
• • Wild-type RAS (determined by an accredited local laboratory, if not available by pathology of Mannheim university)
• • RAS wild-type tested in
• • KRAS exon 2 (codons 12/13)
• • KRAS exon 3 (codons 59/61)
• • KRAS exon 4 (codons 117/146)
• • NRAS exon 2 (codons 12/13)
• • NRAS exon 3 (codons 59/61)
• • NRAS exon 4 (codons 117/146)
• • Informed consent of the patient
• • Aged at least 18 years
• • WHO Performance Status 0-2
• • Life expectancy of al least 12 weeks
• * Adequate haematological, hepatic, renal and metabolic function parameters:
• • Leukocytes \> 3000/mm³
• • ANC ≥ 1500/mm³
• • Platelets ≥ 100,000/mm³
• • Hb \> 9 g/dl
• • Creatinine clearance ≥ 50 ml/min and serum creatinine ≤ 1.5 x upper limit of normal
• • Bilirubin ≤ 1.5 x upper limit of normal
• • GOT-GPT ≤ 2.5 x upper limit of normal
• • AP ≤ 5 x upper limit of normal
• • Magnesium ≥ lower limit of normal
• • Calcium ≥ lower limit of normal
• Exclusion Criteria:
• • Lower border of the tumor localised more than 12 cm ab ano as measured by rigid rectoscopy
• • Distant metastases (to be excluded by CT scan of the thorax and abdomen)
• • cT4 tumor (as determined by MRI and/or endorectal ultrasound)
• • Risk of tumor involvement of the circumferential resection margin, according to the MRI assessment
• • Sphincter sparing is the major reason for choosing the neoadjuvant treatment approach
• • Prior antineoplastic therapy for rectal cancer
• • Prior radiotherapy of the pelvic region
• • Major surgery within the last 4 weeks prior to inclusion
• • 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 (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly)
• • Serious concurrent diseases
• • On-treatment participation in a clinical study in the period 30 days prior to inclusion
• • Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment
• • History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
• • History of HIV infection
• • Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
• • Known allergic reactions on study medication