Neoadjuvant Radiochemotherapy Combined With Panitumumab in Locally Advanced KRAS Wild-type Rectal Cancer

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.