Download Clinical Trials at the Bank of Cyprus Oncology Centre

Clinical Trials at the Bank of Cyprus Oncology Centre
(As of January 2016)
YEAR
OPENED
TRIAL NAME
Multicenter international study of oxaliplatin/5fu-lv in the
adjuvant treatment of colon cancer – “MOSAIC” study.
Investigator(s)
YEAR
CLOSED
Dr. Papamichael
2006
Dr. Papamichael
2008
Multicentre Phase III open label randomised trial
comparing cpt-11 in combination with 5-fu/fa infusional
regimen to the same 5 fu/fa infusional regimen alone
as
adjuvant
treatment
of
stage
III
colon
cancer“PETACC-3”
Dr. Papamichael
2008
2001
The international tirapazone triple trial
Dr. Papamichael
2003
2002
A Phase III, randomized efficacy and safety study of
the combination chemotherapy with tirapazamine +
cisplatin + vinorelbine in subjects with inoperable,
previously untreated, non-small cell lung cancer.
Dr. Adamou
2003
1999
2000
2000
2002
2002
A randomised trial to assess the role of irinotecan and
oxaliplatin in advanced colorectal cancer - focus-(MRC
-Medical Research Council-Uk) “FOCUS” study.
A multicenter Phase III randomized trial comparing
doxorubicin and cyclophosphamide followed by
docetaxel
(AC-T),
with
doxorubicin
and
cyclophosphamide followed by docetaxel and
trastuzumab (AC-TH) and with docetaxel, platinum salt
and trastuzumab (TCH) in the adjuvant treatment of
node positive and high risk node negative patients with
operable breast cancer containing the her2neu
alteration. BCIRG (006)
A multicenter Phase III randomized trial comparing
docetaxel in combination with doxorubicin and
cyclophosphamide (TAC) versus doxorubicin and
cyclophosphamide followed by docetaxel ( AC-T ) as
adjuvant treatment of operable breast cancer her2neu
negative patients with positive axillary lymph nodes.
BCIRG (005)
(created by L. Georgiou)
Dr. Adamou
Dr. Kakouri
Dr. Adamou
2014
Dr. Kakouri
Page 1 of 7
2003
2003
2004
2004
2005
2007
2007
A randomized Phase III Study of follow up with or
without
adjuvant
Gefitinib
(Iressa)
following
chemotherapy in patients with advanced non-small cell
lung cancer. EORTC (8021)
Three dimensional conformal radiotherapy / intensity
modulated radiotherapy alone vs three dimensional
conformal therapy / intensity modulated radiotherapy
plus adjuvant hormonal therapy in localized t1b-c, t2a,
n0, m0 prostatic carcinoma. EORTC radiotherapy
group - a Phase III randomized study – EORTC
(22991)
International prophylactic cranial irradiation trial. A
multicenter randomized trial of high versus standard
doses of prophylactic cranial irradiation in limited small
cell lung cancer complete responders - EORTC (200308004) pc199-eulint1
Dr. Papamichael
2012
Dr. Decatris
Dr. Kitsios
2014
Dr. Katodritis
2010
Prophylactic cranial irradiation in extensive disease
small cell lung cancer EORTC (22993-08993).
Dr. Katodritis
2010
A randomized, open- label Phase II Study evaluating
the efficacy and safety of FOLFOX6 + Cetuximab
versus FOLFIRI plus Cetuximab as first line therapy in
patients with metastatic colorectal cancer. “CECOG”
study
Dr. Papamichael
International, Randomized, Open-Label, Phase III Trial
of Paclitaxel/Carboplatin plus PF3512676 versus
Paclitaxel/Carboplatin alone as first-line treatment of
patients with advanced non-small cell lung cancer.
(A8501001)
A two-arm phase II randomised trial of intermittent
chemotherapy plus continuous cetuximab and of
intermittent chemotherapy plus intermittent cetuximab
in first line treatment of patients with K-ras-normal
(wild-type) metastatic colorectal cancer. “COIN-B”
study MRC – CR-11
(created by L. Georgiou)
Dr. Decatris
2008
2008
Dr. Papamichael
Page 2 of 7
2007
2007
2008
2008
2010
2010
Immediate or early salvage post-operative external
radiotherapy combined with concomitant and adjuvant
hormonal treatment versus immediate or early salvage
postoperative external radiotherapy alone in pT3a-b
R0-1 cN0M0 / pT2R1 cN0M0, Gleason score 5-10
prostatic carcinoma. A Phase III study EORTC (2204330041)
Dr. Kitsios
A Multicenter, Randomized, Double-Blind, Phase III
Study Of Sunitinib In Metastatic Colorectal Cancer
Patients Receiving Irinotecan, 5-Fluorouracil And
Leucovorin (Folfiri) As First Line Treatment.
“THE SUN TRIAL”
Dr. Papamichael
A Phase III Randomized, Double-blind, Placebo
Controlled Trial Comparing
the
Efficacy of
Gemcitabine, Cisplatin and Sorafenib to Gemcitabine,
Cisplatin and Placebo in First-Line Treatment of
Patients with Stage IIIb with effusion and Stage IV nonsmall cell lung cancer. “NExUS” study.
Dr. Charalambous
2010
2011
Dr. Decatris
A Multinational, Randomized, Double-Blind Study,
Comparing the Efficacy of Aflibercept Once Every 2
Weeks versus Placebo in Patients Treated with
Gemcitabine for metastatic pancreatic cancer
“VANILLA” study.
Dr. Papamichael
International Validation Study of the European
Organization for Research and Treatment of Cancer
Brain Module (EORTC-QLQ-BN20) Quality of Life
group measure with EORTC-QLQ-C30 for Assessing
Quality of Life in Patients with Brain Metastases: A
study conducted on behalf of the EORTC (Quality of
Life Questionnaire BN20-C30)
Dr. Vasiliou
International Cross-Cultural Field Validation of an
EORTC Questionnaire Module for Patients with Bone
Metastases EORTC (QLQ-BM22)
Dr. Vasiliou
(created by L. Georgiou)
2013
2011
2011
2011
Page 3 of 7
2011
2011
2011
2011
2011
2012
2012
An open-label, randomized, controlled, multi-center,
Phase 1/11 trial investigating 2 EMD 525797 doses in
combination with cetuximab + irinotecan versus
cetuximab + irinotecan alone, as second-line treatment
for subjects with k-ras wild type (WT) metastatic
colorectal cancer (mCRC). Subjects with k-ras WT
mCRC will be eligible for enrollment if they are
refractory
to
or
progressive
after
first-line
chemotherapy
with
an
oxaliplatin-containing
therapeutic regimen “POSEIDON” study.
An International Field Study of the Reliability and
Validity of an EORTC Older Person-Specific Quality of
Life (QOL) Questionnaire Module (the EORTC QLQELD15) and EORTC QLQ-C30 in assessing the QOL
of cancer patients aged 70 years and above. EORTC
(QLQ-ELD15 and QLQ-C30)
Dr. Papamichael
Dr. Vasiliou
(Colorectal Cancer Trial) - Is greater downstaging and
tumour regression observed when surgery is delayed
to 12 weeks after completion of Chemoradiotherapy vs
6 weeks?
Dr. Vasiliou
Monitoring response to systemic and regional
chemotherapy using dynamic contrast enhanced
ultrasonography DCE-US. Evaluation of Possible
surrogate response markers for efficacy and toxicity.
Dr. Kountourakis
A non-interventional follow-up to the MOSAIC study
(multicentre international study of Oxaliplatin/5Fluorouracil/Leucovorin in the adjuvant treatment of
colon cancer) up to 10 years and translational research
“MOSAIC EXTENSION”(C09-2)
Dr. Papamichael
A Randomised, Open-Label, Proof-of-Concept, Phase
II Trial Comparing Gemcitabine with and without IMM101 in Advanced Pancreatic Cancer (IMM-101-002)
Double blind randomized phase III study of
maintenance pazopanib versus placebo in NSCLC
patients, non progressive after first line chemotherapy.
MAPPING, an EORTC Lung Group study.
(created by L. Georgiou)
2014
2012
2014
Dr. Polyviou
2012
Dr. Papamichael
Dr. Kountourakis
Dr. Charalambous
2013
Page 4 of 7
2012
Treatment of patients with KRAS wild type advanced
colorectal cancer with 5-fluorouracil (5-FU) or 5-FU
plus an Epidermal Growth Factor Receptor inhibitor
(cetuximab) based on a Comprehensive Geriatric
Assessment. EORTC.
2012
BISphosphonates use in solid tumours. REGistry for
collecting the impact of treatment of bone metastases
from solid tumours
2013
A phase I, open-label, multicentre, 3-period, fixed –
sequence study to investigate the effect of
Vemurafenib on the pharmacokinetics of a single dose
of Tizanidine (A CYP1A2 Substrate) in patients with
BRAF V600 mutation-positive metastatic malignancy
2013
2013
2013
2013
2013
A phase IV, postmarketing, open-label, extension
(rollover) study of Vemurafenib in patients with BRAF
V600 mutation-positive malignancies previously enrolled
in an antecedent Vemurafenib protocol
A phase III prospective, two-cohort non-randomized,
multi-centre, multinational, open label study to assess
the safety of assisted- and self- administered
subcutaneous Trastuzumab as therapy in patients with
operable HER-2-positive early breast cancer [SafeHer
Study]
Development of a module to supplement the EORTC
Core instruments for assessment of Health Related
Quality of Life in patients with Anal Cancer(phases I-IV)
Screening Platform of the EORTC for Clinical Trials
in Advanced Colorectal cancer “SPECTAcolor”
Creation of symptom based questionnaires based on
current guidelines for module development: the
development of a time-efficient procedure GIST
EORTC (phases I-IV)
(created by L. Georgiou)
Dr. Papamichael
Dr. Kitsios
2015
Dr. Decatris
Dr. Orphanos
Dr. Katodritis
Dr. Orphanos
Dr. Katodritis
Dr. Decatris
Dr. Marcou
2013 (for
CY)
Dr. Vasiliou
Dr. Papamichael
Dr. Kountourakis
Dr. Vasiliou
Page 5 of 7
Dr. Katodritis
2014
2014
2014
2014
2014
2015
2015
2015
Update of the EORTC Questionnaire for assessing the
quality of life in lung cancer patients (EORTC. QLQ –
LC13)- (Phases I to IV)
Dr. Vomvas
Adaptation of the EORTC IN-PATSAT32 in a core
cancer patient satisfaction with care questionnaire
(PATSAT-CORE x items) and development of a
complimentary module for the outpatient setting
(phases I-IV)
Dr. Vasiliou
A Prospective, Multicenter, Randomized, Double Blind,
Placebo controlled, 2-Parallel Groups, Phase 3 Study
to compare the efficacy and safety of Masitinib in
combination with Folfiri (Irinotecan, 5-Fluorouracil and
Folinic Acid) to Placebo in combination with Folfiri In
second line treatment of patients with Metastatic
Colorectal Cancer
A prospective, multicenter, randomised, open-label,
activecontrolled, two-parallel groups, phase 3 study to
compare the efficacy and safety of masitinib to sunitinib
in patients with gastrointestinal stromal tumor after
progression with imatinib
Dr. Georgiou
Dr. Papamichael
Dr. Kountourakis
Dr. Orphanos
Dr. Papamichael
Μελέτη φάσης ΙΙ μιας ομάδας θεραπείας με aflibercept
ως θεραπεία συντήρησης μετά από πρώτης γραμμής
θεραπεία με FOLFIRI σε συνδυασμό με aflibercept σε
ασθενείς με μεταστατικό κολοορθικό καρκίνο.
Dr. Kountourakis
A multi-centre randomised clinical trial of biomarkerdriven maintenance treatment for first-line metastatic
colorectal cancer (MODUL) A Phase II study
Dr. Papamichael
A Disease Registry Study To Prospectively Observe
Treatment Patterns And Outcomes In Patients With
Her2-Positive Unresectable Locally Advanced Or
Metastatic Breast Cancer
Dr. Marcou
A Phase II study of Switch Maintenance
Pembrolizumab in patients with Non Small Cell Lung
Cancer (NSCLC) who do not progress after First Line
Platinum Doublet Chemotherapy
(created by L. Georgiou)
Dr. Papamichael
2015 (for
CY)
Dr. Kountourakis
Dr. Kakouri
Dr. Charalambous
Page 6 of 7
2015
2015
2015
2016
A phase III, open-label, randomized study of
MPDL3280a (anti−PDL1 antibody) compared with
Gemcitabine + Cisplatin or Carboplatin for PD-L1−
selected, chemotherapy naive patients with stage IV
squamous non−small cell lung cancer
Development of an EORTC cancer survivorship quality
of life questionnaire (Phase I-IV)
Magnetic Resonance Tumour Regression Grade
(mrTRG) as a Novel Biomarker to Stratify Management
of Good And Poor Responders to Chemotherapy: A
Rectal Cancer Multicentre Randomised Control Trial
A prospective, multicentre, double-blind, randomized,
placebo-controlled, phase 3 study to evaluate efficacy
and safety of masitinib with irinotecan in patients with
advanced-stage esophagogastric adenocarcinoma who
have relapsed after first-line chemotherapy
(created by L. Georgiou)
Dr. Charalambous
Dr. Vasiliou
Dr. Vasiliou
Dr. Kountourakis
Dr. Papamichael
Page 7 of 7