ETUDES

ETUDES
Service d'Oncologie - Radiothérapie
Février 2011
SEIN-NEO ADJUVANT
SEIN ADJUVANT
Aging - B32220096117: Elderly biomarker study Gene polymorphisms and gene products as biological markers of
aging and correlation with clinical geriatric assessment, tolerance of chemotherapy and outcome in elderly breast cancer
patients (“Biology of aging and chemotherapy tolerance”)
MINDACT : A prospective, randomised study comparing the 70-gene expression signature with common clinicalpathological criteria in selecting patients for adjuvant chemotherapy in patient with ≤ N1 breast cancer.
Date d’ouverture : mars 2007
SNP Radiothérapie GAND : modèle prédictif pour les effets secondaires au niveau de la peau à la suite d’une
radiothérapie.
Date d'ouverture: Mars 2010
D-Care : Amgen 20060359 : A randomized, double-blind, placebo-controlled, multi-center phase 3 study of
Denosumab as adjuvant treatment for women with early stage breast cancer at high risk of recurrence.
Date d'ouverture: Octobre 2010
SOLD : phase III study comparing trastuzumab plus docetaxel followed by FEC to the same regimen followed by
single-agent trastuzumab as adjuvant treatments for early breast cancer.
Date d'ouverture: Mai 2010
CYP-TAMBRUT 2: An observational study to assess response to tamoxifen with measurable but inoperable or
metastatic ER-positive breast cancer by the the ‘tamoxifen activity score’ based on drug interaction and polymorphisms in
gens coding for tamoxifen metabolising enzymes.
Date d'ouverture: Mai 2010
SOLE : Cont letrozole vs intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for
postmenop women with hormone-receptor +, node positive early stage BC
Date d'ouverture: Octobre 2010
SEIN METASTASE
TRIO-CIRG 012 : IMC-1121B + Docetaxel vs placebo + docetaxel in previously untreated patients with unresectable
locally advanced or MBC HER neg
Date d’ouverture : 17 juin 09
COMPLETE (EGF108919) : Comparison of Lapatinib Efficacy vs Trastuzumab, each with a taxane , 1° line in MBC
Date d’ouverture : septembre 2008
BOLERO-3 : Herceptine and Vinorelbine +/- Everolimus in 2nd or 3rd line MBC pre-treated with a taxane and resistant
to trastuzumab
Date d'ouverture : janvier 2010
PHEREXA : 2° line Herc + Xeloda +/- pertuzumab in MBC HER2+ that have progressed after one line trastuzumabbased therapy in the metastating setting
Date d'ouverture : 10 février 2010
CMSE_Oncologie_Clinique_du_Sein_Etudes_2011.doc
THYME: AZD8931 in combination with paclitaxel in patients with advanced solid tumours and in selected population
with low HER2-expressing.
Date d'ouverture : septembre 2010
NSCLC
PROCLAIM (H3E-MC-JMIG) : Phase III ALIMTA Cisplatine et RT followed by consolidation ALIMTA versus
Etoposide, cisplatine + RT followed by consolidation CT of choice in patients with NSCLC other than squamous cell
Date d’ouverture : septembre 08
RAD002-Stereotaxy : Phase II for primary fractionated stereotactic body radiation therapy for stage T1 – T3N0
NCLCarcinoma.
Date d’ouverture : octobre 2008
BI trial 1200.41 : Etude de phase II déterminant l’efficacité du BIBW2992 dans le NSCLC de stade IIIb ou IV
(adénocarcinome ou bronchioalvéolaire). 3 groupes de patients : 1. Maladie progressive après un EGFR TKI réversible avec
une mutation active de l’EGFR ; 2. Mutation EGFR négative et FISH positif, jusqu’à 3 lignes de chimio ; 3. Mutation dans le
domaine HER2-neu kinase
Date d’ouverture : mars 09
AMGEN 20070782 : Aranesp en double aveugle chez les patients anémiques (Hb < = 11 g/dl) dans le NSCLC
Date d’ouverture : juillet 09
SQUIRE (IMCLONE 0806): PPD : Global phase III study in 1st line treatment of patients with squamous stage IIIb or IV
NSCLC
Date d'ouverture: janvier 2010
MAGRIT : Mage-A3 as adjuvant non-small-cell lung cancer Immunotherapy
Date d'ouverture: septembre 2010
SCLC
EORTC 08072 CONVERT : A 2-arm randomized controlled trial of concurrent CT RT twice daily RT in patients with
limited SCLC+ centre satellite
Date d’ouverture : Mai 09
PROSTATE
EORTC 22043-30041 : postoperative RXT with adjuvant HT vs postoperative RXT alone in prostate cancer (pT3-pT2
N0M0).
Date d’ouverture : Mars 2010
Millenium C21004 : A phase 3, randomized, double-blind, multicenter trial comparing Orteronel (Tak-700) plus
prednisone with placebo plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer.
Date d’ouverture : Décembre 2010
COLON – RECTUM - ESTOMAC
PETACC- 6 : Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatine
vs capecitabine alone in locally advanced rectal cancer.
Date d’ouverture : octobre 2008
DOGE : Etude randomisée de phase II- comparant une administration toutes les 2 semaines à une administration
hebdomadaire de taxotère-cisplatine-5FU dans le cancer gastrique ou de la jonction gastro- oesophagienne avancé.
Date d’ouverture : Mai 2009
Ce
Axe-BEAM : A randomized phase II of bevacizumab, capecitabine and radiation therapy +/- oxaliplatin in the
preoperative treatment of locally advanced rectal disease
Date d’ouverture : mai 2009
AVASTAY : ML22519 : Phase III study : treatment beyond progression by adding Bevacizumab to Xelox
chemotherapy in patients with metastatic CRC and disease progression under 1st line FOLFIRI + Bevacizumab
Date d’ouverture : mai 2009
AVASTART : ML25117: A study to observe in daily clinical practice the treatment duration of patients treated with
Avastin in 1st line mCRC in Belgium
Date d'ouverture: décembre 2009
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VUB08001 : Activity of sunitinib in oesophagia
Date d’ouverture : février 2010
ORL
VLK Dose-Reductie : Dose de-escalation to the elective nodal sites, the swallowing apparatus and neck soft
tissues for head and neck cancer: multi-centre, randomized phase III trial using image-guided intensity-modulated
radiotherapy (IG-IMRT)
Date d’ouverture : Juillet 08
GETTEC 2008-01: Assessment of regional response with PET-FDG in advanced head and neck squamous cell
carcinoma
Date d'ouverture: Décembre 2009
GORTEC 2008-03 TPEX : Association de Cetuximab, docetaxel, cisplatine en 1ère ligne
épidermoîdes Tête et cou métastaiques ou récidivants
Date d'ouverture: Septembre 2010
des cancers
CERVEAU
TUMEURS SOLIDES
TRC112765 :GSK study with eltrombopag Administered to Patients with Solid Tumors Receiving Gemcitabine
monotherapy or Gemcitabine Plus Carbo or Cisplatin
Date d’ouverture : Octobre 2010
URO GENITAL
MITO-8: Second line in ovarian primary : randomisation between carbo-taxol and Caelyx
Date d’ouverture : octobre2009
OVHIPEC : Phase III randomised clinical trial for stage III ovarian randomising between secondary debulking surgery
+/- hyperthermic intraperitoneal chemotherapy.
Date d’ouverture : février 2010
AURELIA : MO22224 (Roche) : a multi-centre, randomised, two-arm phase III trial of bevacizumab plus
chemotherapy verusus chemotherapy alone inpatients with platinum-resistant, epithelial ovarian, fallopian tube or primary
peritoneal cancer.
Date d'ouverture: Mai 2010
National Plan cancer for gynecologic cancer for single polymorphism analysis (Leuven)
Date d'ouverture: Mai 2010
XL147-201 : A phase 2 study of xL147 in subjects with advanced or recurrent endometrial carcinoma.
Temporairement suspendu
REIN
IPSOC : Etude observationnelle ayant pour objectif d’analyser l’accompagnement pharmacothérapeutique des
patients cancéreux atteints de carcinome métastasique à cellules rénales, traités par des médicaments anticancéreux oraux.
ETUDES EN PROJET
NEO-BIG 01-09 (SEIN) : Luminal B trial.
Marianne - Bo22589
AZD4547 : Etude de phase II étudiant l’association de l’AZD4547 avec l’exemestane chez des patients présentant
un cancer du sein ER+ qui ont progressé après une première thérapie endocrine
WT1-AS15-BRS-001 : a double blind, placebo-controlled phase I/II sudy of neoadjuvant and adjuvant treatment with
WT1-A10 + AS15 antigen specific cancer immunotherapeutic in combination with standard therapy in women with WT1positive stage II or III breast cancer
EORTC 10054 (Lapatax) : Trial phase I-II study of Lapatinib and Docetaxel as neoajuvant treatment for HER-2
positive locally advanced/inflammatory or large operable breast cancer
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EORTC 10093 : Pilot study of secondary adjuvant treatment with Trastuzumab for elimination of hER2 positive
Circulating Tumor cells in women with HER2 neg early breast cancer.
ANABEL: A muticenter , post authorization study to observe in daily clinical practice the progression of free-survival
in patients who receive AVASTIN in 1st line MBC in Belgium
EGF114299 : Safety and efficacy of lapatinib + trastuzumab + aromatase inhibitor (AI) vs trastuzumab + an AI vs
lapatinib + AI as 1stline in postmenop with hormone receptor +, HER2+ MBC who have received trastuzumab and endocrine
therapy in neoadjuvant and/or adjuvant setting.
Belgian Cancer Pain Survey: Prevalence of cancer pain and breakthrough pain (non-interventional study)
EORTC 22086 : Radiotherapy vs Temozolomide alone vs radiotherapy and Temozolomide for patients with 1p/19q
codeleted anaplastic glioma.
EORTC 40101 : Phase III trial of cisplatin and 5FU +/- Panitimumab in non resectable, advanced or M+ oesphageal
squamous cell cancer
Everest II : Non Randomized Phase II, open label, dose escalation in experimental arm, non- comparative,
multicenter, multinational patient with unresectable metastatic CRC, K-RAS wild type tumour, eligible for treatment with
cetuximab with irinotecan and 5FU/LV in a first setting
EORTC 08092 (Mapping) : Pazopanib vs placebo in NSCLC patients non progressive after first line chemotherapy.
EORTC22071-24071: postoperative chemoradiation +/- antiEGFR Ab in HNSCC.
Olaparib 1 – Phase II study to compare efficacy and tolerability of Olaparib with paclitaxel and Carboplatine versus
Carboand paclitaxel in platinium sensitive advanced serous ovarian cancer
TRINOVA-2 (Amgen 20060517) : Etude de phase 3, randomisée, en double aveugle avec le Caelyx + l’Amgen 386
versus placebo chez des femmes ayant un cancer de l’ovaire récurrent, partiellement sensible ou résistant aux sels de platine.
BI1199.5 : Investigate the efficacy and safety of BIBF 1120 with carboplatin and paclitaxel compared to a placebo
plus carboplatin and paclitaxel in pt with advanced ovarian cancer
EISAI : Deuxième ligne de traitement avec l’E7080 chez des sujets atteints d’un cancer de l’endomètre avancé
VEG113387 : A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of
pazopanib as adjuvant therapy for subjects with localized or locally advanced RCC following nephrectomy.
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