’08 4e jaargang # 1 | maart
2 Uitgelicht: SCRIPT CKTO 2003-16 Uitgelicht: CAIRO-3 CKTO 2006-17 3 Agenda 4 Nieuwe trials 6 Patiëntendeelname trials | datamanagement 12 Patiëntendeelname | laatste 3 jaar
door IKST en ziekenhuizen
Trialnieuws PATIËNTENDEELNAME TRIALS IKST-REGIO 200 175 150 125
EORTC
100 CKTO
75 50
Industrie/anderen
25 Totaal 1999
2000
2001
2002
2003
2004
2005
2006
2007
TRIALNIEUWS voor medisch specialisten | verpleegkundigen | trialnurses | datamanagers in de IKST-regio
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UITGELICHT
SCRIPT CKTO 2003-16 De doelstelling van SCRIPT is bij patiënten met een operabel rectumcarcinoom op gerandomiseerde wijze na te gaan, of toevoeging van chemotherapie aan gestandaardiseerde TME-chirurgie en pre-operatieve radiotherapie de totale overleving verbetert en het aantal lokale en afstandsrecidieven vermindert. Patiënten met TNM-stadium II of III, adenocarcinoom van het rectum en patiënten die zijn voorbestraald met 5 x 5 GY, komen voor deze studie in
aanmerking. Patiënten die voor chemotherapie loten, ontvangen Capecitabine. In de IKST-regio doet het Streekziekenhuis Koningin Beatrix (Winterswijk) mee aan deze studie. Het centrale datamanagement loopt via het Datacentrum Heelkunde LUMC. • Meer informatie www.ikst.nl > onderzoek > trialoverzicht
CAIRO-3 CKTO 2006-17
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Bij patiënten met een uitgebreid colorectaal carcinoom wordt na eerstelijns inductietherapie met Capecitabine, Oxaliplatin en Bevacizumab gerandomiseerd voor onderhoudsbehandeling met Capecitabine en Bevacizumab of observatie. Patiënten in beide randomisatiearmen worden bij progressie weer behandeld met de initiële therapie. In de IKST-regio doen het Deventer Ziekenhuis, Medisch Spectrum Twente, Streekziekenhuis Koningin Beatrix en de
beide locaties van Ziekenhuisgroep Twente mee aan de studie. Landelijk zijn ongeveer 80 patiënten aangemeld, waarvan drie uit de IKST-regio (25-022008). Het centrale datamanagement loopt via het Integraal Kankercentrum Oost (IKO) in Nijmegen. • Meer informatie www.ikst.nl > onderzoek > trialoverzicht
AGENDA
ZIE OOK WWW. IKCNET. NL
| • agenda
• 8 april 2008 NVvOD scholingsdag Locatie | Medisch Centrum Leeuwarden | 10.00 - ± 17.00 uur Tijd
• 15 - 19 april 2008 6e European Breast Cancer Conference (EBCC-6) Locatie | Berlijn
• 7 mei 2008 HOVON, algemene vergadering Locatie | Eenhoorn (Amersfoort) Tijd | 9.00 - 16.30 uur
• 21 mei 2008 BOOG symposium Locatie | LUMC (Leiden) Tijd | 17.30 - 21.30 uur
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NIEUWE TRIALS In onderstaand overzicht staat per tumorsoort vermeld welke trials recent van start zijn gegaan of binnenkort starten.
BLOED, BEENMERG EN LYMFKLIER HOVON 75 Bortezomib maintenance therapy in newly diagnosed patients with mantle cell lymphoma, responsive on Rituximab combined with CHOP and high dose Ara-C and after BEAM with auto PSCT rescue HOVON 79/ PETHEMA LPA 2005 Remission induction with ATRA + Idarubicin. Risk-adapted consolidation with ATRA and Anthracycline-based chemotherapy (Idarubicin/Mitoxantrone) with addition of Ara-C for high-risk patients with APL. Maintenance therapy with ATRA + low dose chemotherapy (Methotrexate + Mercaptopurine) HOVON 80 Phase II study on the feasibility and efficacy of R-DHAP + HD-MTX, combined with autologous stem cell transplantation in patients with a recurrent aggressive B-cell lymphoma with CNS localisation HOVON 81 A Phase II multicenter study to assess the tolerability and efficacy of the addition of Bevacizumab to standard induction therapy in AML and high risk MDS above 60 years. A randomized phase II study HOVON 84 Randomized phase III study on the effect of early intensification of Rituximab in combination with 2-weekly CHOP chemotherapy followed by Rituximab maintenance in elderly patients (66-80 years) with diffuse large B-cell lymphoma HOVON 86 Phase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in elderly patients in 1st relapse or primary refractory after first line therapy for multiple myeloma H10, EORTC 20051 Randomized Intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined modality treatment in patients with supradiaphragmatic stage I/II Hodgkin's lymphoma
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BORST ATX, BOOG 2006-06 Phase II randomized trial of combination therapy of Paclitaxel and Bevacizumab
NIEUWE TRIALS versus Paclitaxel, Capecitabine and Bevacizumab as first-line treatment for locally recurrent or metastatic breast cancer patients with HER2-neu negative tumor INTENS, IKO 2005-01 Sequential versus upfront intensified neoadjuvant chemotherapy in patients with large resectable or locally advanced breast cancer SUPREMO, EORTC 22051, EORTC 10052, BOOG 2006-03 Phase III randomised trial to assess the role of adjuvant chest wall irradiation in ‘intermediate risk’ operable breast cancer following mastectomy
LONG EORTC 08062 Randomization phase II study of Amrubicin as single agent or in combination with Cisplatin versus Etoposide-Cisplatin as first-line treatment in patients with extensive stage SCLC (ES) NVALT 8 Adjuvant chemotherapy in PET-selected NSCLC A6181087 A multicentre, randomized, double blind, controlled phase III study, efficacy and safety of Sunitinib in patients with advanced/metastatic NSCLC treated with Erlotinib
SPIJSVERTERINGSKANAAL CRITICS, CKTO 2006-02 Chemo-radiotherapy after induction chemotherapy in cancer of the stomach. A multicenter randomized phase III trial of neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy in resectable gastric cancer
VROUWELIJKE GESLACHTSORGANEN PORTEC-3, CKTO 2006-04 Randomized phase III trial comparing chemoradiation and adjuvant chemotherapy with pelvic radiation alone in high risk and advanced stage endometrial carcinoma VULVASTUDIE, CKTO 2005-25 Phase II of definitive radiochemotherapy for locally advanced squamous cell cancer of the vulva: an efficacy study
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PATIËNTENDEELNAME TRIALS Datamanagement door IKST en ziekenhuizen In dit overzicht staat het totale aantal patiënten (t/m januari 2008) weergegeven dat door de ziekenhuizen in de IKST-regio in trials is aangemeld*. Opgenomen zijn open trials en de trials die na november 2007 zijn gesloten, waarvoor het IKST het datamanagement doet (blauw) en waarvoor de ziekenhuizen zelf het datamanagement doen (rood). Voor het aanleveren van de gegevens van trials die de ziekenhuizen zelf registreren, is het IKST afhankelijk van wat de onderzoekers in de ziekenhuizen aanleveren. Dit deel van het overzicht is niet compleet.
A phase III international randomized trial of single versus multiple fractions for re-irradiation of painful bone metastasis
EURABEL Evaluation of the oral uracil test. A sensitive, simple and cheap
0
0
method to detect DPD deficiency
FRESCO 30
The dutch multicenter, prospective, randomized, controlled trial. Efficacy of fibrin sealant in reducing resection surface-related complications after partial liver resections
STAR 2 Survey on the treatment of anemia using recombinant human
5
erythropoietin
BLOED, BEENMERG EN LYMFKLIER EORTC 20971/22997 13
A phase III randomized study on low-dose total body irradiation and involved field radiotherapy in patients with localized, stages I and II,
6
low grade non-Hodgkin’s lymphoma
HOVON 42, CKTO 2000-08 Randomized induction and post-induction therapy in adult patients
51
with acute myelocytic leukaemia (AML) or refractory anaemia with excess of blasts (RAEB, RAEB-t)
*Bij de ziekenhuizen waar geen cijfer achter de trial staat, loopt de trial niet.
ZGT-TZ
7
BOTMETASTASE, CKTO 2004-06, SC20
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9
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MST
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Deventer Ziekenhuis Gelre ziekenhuizen, locatie Apeldoorn Gelre ziekenhuizen, locatie Zutphen Medisch Spectrum Twente Medisch Spectrum Twente, radiotherapie Radiotherapeutisch Instituut Stedendriehoek en Omstreken Streekziekenhuis Koningin Beatrix Ziekenhuisgroep Twente, locatie SMT Ziekenhuisgroep Twente, locatie Twenteborg Ziekenhuis GZ-A
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BLOED, BEENMERG EN LYMFKLIER HOVON 55, CKTO 2004-03
1
Efficacy of maintenance therapy with Retuximab after reinduction chemo (R-CHOP versus R-FC) for elderly patients with MCL not suitable for autologous stem cell transplantation
HOVON 63, CKTO 2005-13 0
Randomized study of Rituximab with intensified CHOP chemotherapy (R-iCHOP-14) versus Rituximab with high-dose sequential therapy and autologous stem cell transplantation (R-HDT+ASCT) in adult patients (18 - 65 years) with stage II-IV high-intermediate or high risk diffuse large B-cell lymphoma
HOVON 64 1
Anti-CD20 treatment of relapsed or refractory immune thrombocytopenic purpura (ITP) after first line corticosteroid treatment
HOVON 65, CKTO 2004-10 Study on the effect of Bortezomib combined with Adriamycin,
0
2
1
11
3
2
0
Dexamethason (AD) for induction treatment, followed by high dose Melphalan and Bortezomib alone during maintenance in patients with multiple myeloma
HOVON 68, CKTO 2005-07 A randomized phase III study in previously untreated patients with
0
0
biological high-risk CLL: Fludarabine + Cyclophosphamide (FC) versus FC + low-dose Alemtuzumab
HOVON 70, CKTO 2005-08 Feasibility study using repeated intensive chemotherapy courses
1
for patients with primary acute lymphoblastic leukemia in adults age 18 - 39 years inclusive
HOVON 71, CKTO 2005-09 Treatment of acute lymphoblastic leukemia (ALL) in adults age 40 -
2
70 years inclusive with chemotherapy including a pre-induction course for rapid tumor load reduction and prolonged maintenance chemothe-
7
rapy (closed 030108)
HOVON 77, CKTO 2005-19 Efficacy and safety of a single dose of 14.8 MBq/kg (0.4 mCi/kg) 90Y-Ibritumomab Tiuxetan (Zevalin) in elderly patients with diffuse large B-cell lymphoma and FDG-PET positive partial remission
0
ZGT-TZ
ZGT-SMT
SKB
RISO
MST-RT
MST
GZ-Z
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BLOED, BEENMERG EN LYMFKLIER HOVON 77, CKTO 2005-19 vervolg following first-line R-CHOP therapy. A phase II clinical trial
HOVON 78, CKTO 2005-23 2
Imatinib in combination with Cytarabin as compared to Imatinib alone in patients with first chronic phase chronic myeloid leukemia. A prospective randomized study
HUMAX-CD20 0
A double-blind, randomized, two-dose arm, parallel, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with follicular lymphoma who are refractory to Rituximab in combination with chemotherapy
BORST AMAROS, EORTC 10981/22023, BOOG 2001-02 269
After mapping of the axilla: radiotherapy or surgery
BACH study 0
Randomized phase II multinational trial to evaluate the safety of two
0
0
chemotherapy plus Trastuzumab regimens as adjuvant therapy in patients with HER2-positive breast cancer: Caelyx + Cyclophosphamide +Trastuzumab (C+C+H) or Doxorubicin + Cyclophosphamide (A+C), each followed by Paclitaxel + Trastuzumab (T+H)
BOOG 2003-04 Breast cancer in pregnancy
1
CKTO 2004-05, BIG 1-02, IBCSG 27-02, BOOG 2003-02 0
Chemotherapy for radically resected locoregional relapse. A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer - chemotherapy versus observation
DATA, BOOG 2006-01 A prospective randomized, open, multicentre, phase III study to assess
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10
6
16
different durations of Anastrozole therapy after 2 to 3 years. Tamoxifen as adjuvant therapy in postmenopausal women with breast cancer
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FACE A randomized, multicenter phase III b, open label, study of Letrozole versus Anastrozole in the adjuvant treatment of postmenopausal women with hormone receptor and node positive breast cancer (closed 170108)
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0
5
24
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BORST HERTAX, BOOG 2002-02 Open label, comparative, randomized, multicenter, study of Trastuzumab (Herceptin®) given with Docetaxel (Taxotere®) versus sequential single agent therapy with Trastuzumab followed by Docetaxel as first-line treatment for metastatic breast cancer (MBC) patients with HER2-neu overexpression (closed 101207)
IDEAL, BOOG 2006-05 Investigation on the duration of extended adjuvant Letrozole treatment; an open label randomized phase III trial comparing 2.5 year duration of Letrozole (Femara) treatment with 5 year duration in patients previously treated for endocrine sensitive early breast cancer
LEAP 1
Open label study with Lapatinib and Capecitabine for patients with ErbB2 over-expression in locally advanced or metastatic breastcancer
MATADOR, CKTO 2004-04, BOOG 2005-02 Microarray analysis in breast cancer to tailor adjuvant drugs or regimens
24
3
0
MINDACT, EORTC 10041, BOOG 2005-03 Micro arrays in clinical practice for breast cancer
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MYOTAX 8
Phase II multicentre open label trial evaluating the efficacy and safety of the liposomal Doxorubicin (Myocet®) and Docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu negative breast cancer
MYOHERTAX 0
Phase II multicentre open label study evaluating the efficacy and safety of the liposomal Doxorubicin (Myocet®), Tastuzumab (Herceptin®) and Docetaxel (Taxotere®) combination as first line treatment of patients with metastatic HER2/neu positive breast cancer
OMEGA, CKTO 2006-09, BOOG 2006-02 0
A randomized, open label phase II study of first line chemotherapy in older metastatic breast cancer patients, comparing intravenous pegy-
9
lated liposomaal Doxorubicine (Caelyx) with oral Capecitabine; and the incorporation of a complete geriatric assessment
RASTER mRNA expression pattern for the selection of adjuvant therapy for node negative breastcancer
20
A multicenter, phase III, randomized, placebo-controlled trial evalua-
chemotherapy regimens in subjects with previously untreated metastatic breast cancer
TEAM 2b, BOOG 2006-04 The efficacy and safety of the addition of Ibandronate to adjuvant
0
hormonal therapy in postmenopausal women with hormone receptor positive early breast cancer
YOUNG BOOST TRIAL, CKTO 2003-13, BOOG 2004-01 Radiation dose intensity study in breast cancer in young women; randomized trial of additional dose to the tumor bed
LONG NVALT-4, CKTO 2003-14 Randomized placebo-controlled phase II/III study of Docetaxel/
13
Carboplatin with Celecoxib in patients with locally advanced or metastatic non-small cell lung cancer (closed 260208)
NVALT-5, CKTO 2004-09 A phase III trial of the antiangiogenic agent Thalidomide in patients
9
with malignant pleural mesothelioma after first-line chemotherapy
SAHA (MSD) A phase III, randomized, double-blind, placebo-controlled trial of oral
4
Suberoylanilide Hydroxamic Acid in patients with advanced malignant pleural mesothelioma previously treated with systemic chemotherapy
SPIJSVERTERINGSKANAAL AMG 954 A randomized, multicenter phase III study to compare the efficacy
1
of Panitumumab in combination with chemotherapy to the efficacy of chemotherapy alone in patients with previously treated metastatic colorectal cancer
10
CAIRO-3, CKTO 2006-17 Maintenance treatment with Capecitabine and Bevacizumab versus observation after induction therapy with chemotherapy and Bevacizumab as first-line treatment in patients with advanced colorectal cancer, a randomised phase III study
1
1
ZGT-TZ
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ting the efficacy and safety of Bevacizumab in combination with
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SPIJSVERTERINGSKANAAL DROP Preoperative biliary drainage for pancreato-biliary tumors causing
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obstructive jaundice
HEPATICA, CKTO 2006-12 A randomized two arm phase III study in patients post radical resecti-
1
0
on of liver metastasis of colorectal cancer to investigate Bevacizumab (q3w) in combination with Capecitabine plus Eloxatin® (XELOX) (q3w) as adjuvant chemotherapy versus XELOX (q3w) alone as adjuvant treatment SCRIPT, CKTO 2003-16 A multicentre phase III randomized trial comparing total mesorectal
1
excision with pre-operative radiotherapy with or without postoperative oral Capecitabine in the treatment of operable primary rectal cancer T4, CKTO 2004-02 Chemoradiation for irresectable esophageal cancer (closed 141107)
6
UROLOGIE NEPRO A randomized phase II/III study of Risedronate in combination with
3
Docetaxel versus Docetaxel alone in patients with hormone refractory prostate cancer
VROUWELIJKE GESLACHTSORGANEN DOCA-CEL A randomized phase II study investigating the addition of the specific
3
27
COX-2 inhibitor Celecoxib to Docetaxel plus Carboplatin as first-line chemotherapy for stage Ic-IV epithelial ovarian, fallopian tube or primary peritoneal carcinomas
11
meer informatie kunt u vinden op
W W W. I K S T. N L
PATIËNTENDEELNAME LAATSTE DRIE JAAR In onderstaand overzicht staat per ziekenhuis en in totaal weergegeven hoeveel patiënten in 2005, 2006 en 2007 zijn aangemeld in trials waarvoor het IKST het datamanagement doet. totaal 2005 | 168 totaal 2006 | 186 totaal 2007 | 180 Deventer Ziekenhuis Gelre ziekenhuizen, locatie Apeldoorn Gelre ziekenhuizen, locatie Zutphen Medisch Spectrum Twente Medisch Spectrum Twente, radiotherapie RISO Streekziekenhuis Koningin Beatrix Ziekenhuisgroep Twente, locatie SMT Ziekenhuisgroep Twente, locatie Twenteborg Ziekenhuis 0
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Colofon
Meer informatie
Trialnieuws, een uitgave van het IKST, verschijnt twee maal per jaar.
Voor meer informatie over trials en wat het IKST op dit gebied kan betekenen, kunt u contact opnemen met:
Redactie Saskia Lunter [eindredactie], Sabine Siesling en Lieske Stevens Ontwerp en opmaak INVORM grafisch ontwerpen, Enschede Druk te Sligte BV, Enschede Adreswijziging Indien Trialnieuws niet op het goede adres bezorgd is, horen wij dat graag van u. [
[email protected]]
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Informatie Meer informatie over het IKST kunt u krijgen op www.ikst.nl en www.ikcnet.nl
Lieske Stevens | trialconsulent [
[email protected]] t: 053-4305010 Sabine Siesling | hoofd Onderzoek en Registratie [
[email protected]] t: 053-4305010
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