KURZPROTOKOLL OLGA

KURZPROTOKOLL
OLGA-Studie
Öffentlicher Titel
Chemoradiotherapie bei metastasiertem kolorektalem Karzinom
Wissenschaftl. Titel
Capecitabine and bevacizumab with radiotherapy after 3-6 months chemotherapy for
patients with oligometastatic colorectal cancer
Kurztitel
OLGA-Studie
Studienart
multizentrisch, prospektiv, offen/unverblindet, einarmig, Investigator Initiated Trial (IIT)
Studienphase
Phase II
Erkrankung
GASTRO: Kolorektales Karzinom: Erstlinie
RADIO: Verschiedene Tumoren
Ziele
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Progression free survival rate at 12 months after start of induction treatment
(PFSR@12)
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Progression free survival (PFS)
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Time to progression (TTP) in 2 cohorts: a) regards only progression within (TTPir)
and b) in- and outside irradiated areas (“overall” TTP)
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Overall survival (OS)
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Efficacy of the investigational therapy shown by the Overall
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Response Rate (CR and PR)
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Safety, Quality of life (QoL)
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Prognostic and predictive value of PET scan at baseline and at 2 months after
chemoradiation
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ein Ziel
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Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer
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Oligometastatic disease, defined as at least one measurable lesion with size > 1 cm
to a maximum of 3 sites and 5 lesions. (RECIST v1.1)
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Patients being neither progressive nor resectable after 3-6 months of first line
chemotherapy with bevacizumab.
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Maximum treatment interruption after induction therapy of 6 weeks
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ECOG Performance status <= 2
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Life expectancy > 3 months
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Age >=18 years.
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Haematologic function: ANC >=1.5 x 10^9/L, platelets >=75 x10^9/L
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INR <1.5 within 7 days prior to starting study treatment aPTT < 1.5 x ULN within 7
days prior to starting study treatment.
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Adequate liver function as measured by serum transaminases (AST & ALT) <= 5 x
ULN and total bilirubin <= 1.5 x ULN
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Adequate renal function: Serum creatinine <= 1.5 x ULN
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Signed, written informed consent
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Ability to swallow tablets
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Treatment with any other investigational agent, or participation in another clinical trial
within 30 days prior toentering this study.
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Prior radiotherapy for metastatic lesions (prior radiotherapy for primary tumor allowed
if followed by complete resection and no sign for local recurrence at the time of
enrolment).
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Pre History or evidence upon physical/neurological examination of CNS disease
(unrelated to cancer) (unless adequately treated with standard medical therapy) e.g.
uncontrolled seizures.
Einschlusskriterien
Ausschlusskriterien
© Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt
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KURZPROTOKOLL
OLGA-Studie
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Fertile women (< 2 years after last menstruation) and men of childbearing potential
unwilling or unable to use effective means of contraception (oral contraceptives,
intrauterine contraceptive device, barrier method of contraception in conjunction with
spermicidal jelly or surgically sterile).
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Pregnancy or lactation.
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Positive serum pregnancy test within 7 days of startingstudy treatment in premenopausal women and women < 2 years after the onset of menopause. Note: a
negative test has to be reconfirmed by a urine test, should the 7-day window be
exceeded.
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Past or current history (within the last 2 years prior to treatment start) of other
malignancies except metastatic colorectal cancer (patients with curatively treated
basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are
eligible).
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Known DPD-insufficiency
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Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
(defined as > 4 loose stools per day)
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Serious, non-healing wound, ulcer or bone fracture.
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Evidence of bleeding diathesis or coagulopathy.
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Urine dipstick for proteinuria >2+. If urine dipstick is >= 2+, 24-hour urine must
demonstrate <= 1 g of protein in 24 hours for patient to be eligible.
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Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to treatment.
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Clinically significant cardiovascular disease, for example CVA, myocardial infarction (
12 months before treatmentstart), unstable angina, NYHA Class II CHF, arrhythmia
requiring medication, or uncontrolled hypertension.
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Evidence of any other disease, metabolic dysfunction,physical examination finding or
laboratory finding givingreasonable suspicion of a disease or condition
thatcontraindicates the use of an investigational drug or putsthe patient at high risk
for treatment-related complications.
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Concomitant therapy with sorivudin or chemical analogues like brivudin
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Known hypersensitivity or contraindication to the drugs used in the trial (eg:
capecitabine, bevacizumab)
Alter
18 Jahre und älter
Status
Geschlossen
Beginn der Rekrutierung
01.12.2012
Weitere Ansprechpartner
Leiter der klinischen Prüfung
Universitätsklinikum Hamburg-Eppendorf
Prof. Dr. med. Dirk Arnold
Martinistr. 52
20246 Hamburg
Tel: 040 / 7410 51640
Fax: 040 / 7410 51642
[email protected]
Sponsoren
Universitätsklinikum Eppendorf (Hauptsponsor)
Förderer
Universitätsklinikum Eppendorf
Registrierung in anderen
Studienregistern
ClinicalTrials NCT01759238
EUDRACT 2011-005296-16
© Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de
Stand: 16.01.2017; Seite 2 von 2