eoadjuvant Radiochemotherapy Combined with Panitumumab in Locally Advanced KRAS wild-type Rectal Cancer - NeoRec-1
- Conditions
- 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: 13.1Level: LLTClassification code 10038052Term: Rectal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-009277-10-DE
- Lead Sponsor
- niversity Hospital Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
oHistologically 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.
oWild-type KRAS.
oECOG-performance status 0 or 1.
oAge = 18 years.
oLaboratory 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.
oNegative ß-HCG-serum pregnancy test (females of child bearing potential).
oWilling to use double-barrier contraception during study and for 6 months after the end of treatment.
oAbility of patient to understand character and individual consequences of clinical trial
oWritten 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
oPrior EGFR targeting or prior chemo- or radiotherapy or tumor surgery.
oEvidence of any distant metastases.
oManifest or previous secondary malignancies within the last 5 years.
oUncontrolled infection.
oClinically 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.
oHistory of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on screening chest CT scan.
oDiabetes mellitus
oSubject pregnant or breast feeding, or planning to become pregnant within 6 month after the end of treatment.
oSubject (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.
oActive serious illness which renders the patient unsuitable for study entrance, multiple blood sampling or the above mentioned biopsies.
oHistory 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.
oParticipation in other clinical trials or observation period of competing trials, respectively.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>(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 Outcome Measures
Name Time Method 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<br>Before surgery (week 12) tumor response rates will be reassessed by MRI of the pelvis and FDG-PET-CT