CONKO-005: Adjuvante Therapie des R0-resezierten Pankreaskarzinoms mit Gemcitabin plus Erlotinibversus Gemcitabin über 24 Wochen – eine prospektive, randomisierte, Phase III Studie - CONKO-005

Phase 1

• Conditions: pancreatic canceradjuvant therapy after R0-resectionGemcitabine plus Erlotinib vs. Gemcitabine mono, given over 24 weeksrandomised trial

• Registration Number: EUCTR2007-003813-15-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-26
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

R0-resection
histologically confirmed diagnosis of an adenocarcinoma of the pancreas
no previous neoadjuvant anticancer treatment
karnofsky performance status > = 60%
patient compliance
signed informed consent
sufficient blood cell count
age > = 18 years
beginning of the chemotherapy between week 2-8 post OP, wound healing must be completed
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Other serious illness: uncontrolled hypertension, congestive heart failure (NYHA III-IV), symptomatically coronary heart disease, uncontrolled cardial arrythmia > grade 2, occlusive periphere arterial disease > stage IIb
other serious illness with life expectancy < 6 month
active infection > grade 2 NCI-CTCAE v3.0
impaired renal or liver function
postoperative mesurable tumorlesion
pregnant or braestfeeding patients. Woman of childbearing potential must have a negative pregnancy test performewd 7 days prior to start of the traetment
sexually active males and females with child-bearing potential unwilling to practice sufficient contraception during the study and for 3 month after end of study medication
known allergic reactions against the study drugs or the substances included therein
patients undergoing renal dialysis
interstitial pneumonia or symptomatic fibrosis of the lung
immuno-suppressive therapy (e.g. allogeneic transplantation)
severe non-healing wounds, ulcers or bone fractions
enrollment in another clinical trial
previous or ongoing narcotic drug, medication or alcohol abuse
patients which are not able to take in oral drugs, need parenteral nutrition, are known to have an insufficient gastrointestinal resorption or suffer from acute stomach ulcer
other primary malignancy in the patient's history (except for successfully treated basalioma or carcinoma in situ of the cervix uteri)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified