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, but without evidence of distant metastases. MedDRA version: 13.1 Level: LLT Classification code 10038052 Term: Rectal carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Vectibix
Product Name: Panitumumab
Pharmaceutical Form:
INN or Proposed INN: PANITUMUMAB
CAS Number: 339177-26-3
Current Sponsor code: none
Other descriptive name: none
Concentration unit
Sponsors
University Hospital Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o 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. o Wild-type KRAS. o ECOG-performance status 0 or 1. o Age = 18 years. o 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. o Negative ß-HCG-serum pregnancy test (females of child bearing potential). o Willing to use double-barrier contraception during study and for 6 months after the end of treatment. o Ability of patient to understand character and individual consequences of clinical trial o Written informed consent (must be available before enrolment in the trial) 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: o Prior EGFR targeting or prior chemo- or radiotherapy or tumor surgery. o Evidence of any distant metastases. o Manifest or previous secondary malignancies within the last 5 years. o Uncontrolled infection. o 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 enrolment/randomization. o History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on screening chest CT scan. o Diabetes mellitus o Subject pregnant or breast feeding, or planning to become pregnant within 6 month after the end of treatment. o 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. o Active serious illness which renders the patient unsuitable for study entrance, multiple blood sampling or the above mentioned biopsies. o 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. o Participation in other clinical trials or observation period of competing trials, respectively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the anti-tumor efficacy of Panitumumab with combined radiochemotherapy with respect to the pCR rate.;Secondary Objective: Secondary objectives include metabolic, objective response, and further pathological efficacy parameter as well as safety parameter and quality of life.;Primary end point(s): The primary endpoint is the histopathological complete response rate (pCR) determined by means of the resection specimens.;Timepoint(s) of evaluation of this end point: At the end of study (week 14 +/-7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be objective tumor response rates of the pelvis and metabolic tumor response rates assessed by means of changes in the standardized uptake values (SUV) using FDG-PET-CT. Further secondary endpoints are the rate of R0 and sphincter preserved resections.;Timepoint(s) of evaluation of this end point: At day 14 by MRT Before surgery (week 12) tumor response rates will be reassessed by MRI of the pelvis and FDG-PET-CT | — |
Countries
Germany
Contacts
Public ContactPrinicpal Investigator
NCT Heidelberg
Outcome results
None listed