Neoadjuvant Radiochemotherapy Combined With Panitumumab in Locally Advanced KRAS Wild-type Rectal Cancer (NEOREC-1)

This is an interventional treatment trial for Rectal Cancer focused on measuring Neorec, rectal cancer, KRAS, Panitumumab, neoadjuvant, Radiochemotherapy, antibody, locally advanced KRAS wild type rectal cancer Read More

Inclusion Criteria:

• Histologically 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.
• Wild-type KRAS.
• ECOG-performance status 0 or 1.
• Age ≥ 18 years.

• Laboratory 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.
• Negative ß-HCG-serum pregnancy test (females of child bearing potential).
• Willing to use double-barrier contraception during study and for 6 months after the end of treatment.
• Ability of patient to understand character and individual consequences of clinical trial
• Written informed consent (must be available before enrollment in the trial)

Exclusion Criteria:

• Prior EGFR targeting or prior chemo- or radiotherapy or tumor surgery.
• Evidence of any distant metastases.
• Manifest or previous secondary malignancies within the last 5 years.
• Uncontrolled infection.
• Clinically significant cardiovascular disease NYHA classification III or IV (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment/randomization.
• History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on screening chest CT scan.
• Diabetes mellitus
• Subject pregnant or breast feeding, or planning to become pregnant within 6 month 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.
• Active serious illness which renders the patient unsuitable for study entrance, multiple blood sampling or the above mentioned biopsies.
• History 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.
• Participation in other clinical trials or observation period of competing trials, respectively.