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- Klinische proef NCT01934465
Bevacizumab Plus Chemotherapy for Advanced Non Small Cell Lung Cancer Patients as 1st Line Treatment
Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) Retrospectively and Prospectively as First Line Treatment for Patients With Advanced or Metastatic Non Small Cell Lung Cancer. Assessment of Toxicity, Compliance and Survival of Patients.
Investigators propose to assess, retrospectively and prospectively the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with advanced or metastatic Non Small Cell Lung Cancer.
All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with advanced or metastatic Non Small Cell Lung Cancer.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Alexandroupolis, Griekenland
- University General Hospital of Alexandroupolis, Dept. of Medical Oncology
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Athens, Griekenland
- 401 Military Hospital of Athens
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Athens, Griekenland
- Air Forces Military Hospital of Athens
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Athens, Griekenland
- "IASO" General Hospital of Athens
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Larissa, Griekenland
- State General Hospital of Larissa, Dep of Medical Oncology
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Piraeus, Griekenland
- "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
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Thessaloniki, Griekenland
- "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
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Crete
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Heraklion, Crete, Griekenland
- University Hospital of Crete, Dep of Medical Oncology
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Signed informed consent prior to initiation of any trial-specific procedure or treatment
- Ability to comply with the protocol
- Histologically or cytologically (sample to be obtained by biopsy or bronchoscopy) confirmed non-squamous NSCLC (locally recurrent or metastatic) per investigator assessment
- At least 1 unidimensionally measurable lesion meeting RECIST criteria
- No prior first line treatment for metastatic colorectal cancer
- Age ≥18 years
- ECOG performance status ≤2
- Adequate haematological, renal and hepatic function
- Urine protein <2+ (dipstick)
- International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN within 7 days prior to randomization, unless there is prophylactic use of anti-coagulation
- Patients with asymptomatic treated brain metastases are eligible for trial participation. Patients must complete treatment for brain metastases (radiotherapy with or without surgery, or stereotactic radiosurgery), including steroids, at least 28 days prior to randomization. Treatment with anticonvulsants at the time of randomization (i.e. ≥ 28 days) is allowed as long as the anti-convulsant is at a stable dose)
- Female patients must not be pregnant or breast-feeding. Female patients of childbearing potential (defined as >2 years after last menstruation or surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1% per year, are implants, injectables, combined oral contraceptives, intra-uterine device [IUD; only hormonspirals], sexual abstinence or vasectomized partner) during the trial and for a period of at least 6 months following the last administration of trial drug(s).Female patients with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the trial
- Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1% per year, include a female partner using implants, injectables, combined oral contraceptives, IUDs [only hormonspirals], sexual abstinence or prior vasectomy) during the trial and for a period of at least 6 months following the last administration of trial drug(s)
Exclusion Criteria:
- Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
- History of hemoptysis ≥ grade 2 (defined as bright red blood of at least 2.5 mL) within 3 months prior to randomization
- Surgery (including open biopsy), significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during trial treatment
- Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
- Evidence of tumor invading or abutting a major blood vessel (e.g., pulmonary artery or superior vena cava) on imaging
- Radiotherapy to any site for any reason within 28 days prior to randomization. Palliative radiotherapy to bone lesions within 14 days prior to randomization is allowed
- Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or current or recent (within 10 days prior to first dose of bevacizumab) use of full-dose (i.e. therapeutic dose) oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed.
- History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding
- Active gastrointestinal bleeding
- Inadequately controlled hypertension (blood pressure: systolic > 150 mmHg and/or diastolic > 100 mmHg) within 28 days prior to randomization or history of hypertensive crisis or hypertensive encephalopathy
- Clinically significant (i.e. active) cardiovascular disease (e.g. cerebrovascular accident [CVA] or myocardial infarction within 6 months prior to randomization, unstable angina, congestive heart failure [CHF] New York Heart Association [NYHA] Class ≥ II, or serious cardiac arrhythmia), that is uncontrolled by medication or may interfere with administration of trial treatment
- Non-healing wound, active peptic ulcer or untreated bone fracture
- History of abdominal fistula, gastrointestinal perforation or intra abdominal abscess within 6 months prior to randomization.
- Treatment with any other investigational agent within 28 days prior to randomization. Patients in the follow-up phase of 1st-line trials who fulfill all eligibility criteria may be enrolled in this trial if the 1st-line protocol allows bevacizumab-based treatment in the follow-up phase
- Known hypersensitivity to bevacizumab or any of its excipients, or any of the SOC agents foreseen
- Malignancy other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, and ductal carcinoma in situ (DCIS) treated surgically with curative intent
- Evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational or SOC drug used in this study or puts the patient at higher risk for treatment-related complications
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Avastin regimens
Patients who have either received or who are going to receive chemotherapy plus Avastin (bevacizumab)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants with AE
Tijdsspanne: Every 3 weeks up to 18 weeks
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In this observational study investigators are going to assess standard schedules in which administrations were every 3 weeks.
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Every 3 weeks up to 18 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants with Response Rate
Tijdsspanne: Disease evaluation at Week 6
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In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 6 weeks
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Disease evaluation at Week 6
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Percentage patiënten met progressievrije overleving
Tijdsspanne: 1 jaar
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1 jaar
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Patiënten algehele overleving
Tijdsspanne: 1 jaar
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1 jaar
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Vassilis Georgoulias, MD, Hellenic Oncology Research Group
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CT/10.11
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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