Clinical trial • Phase III • Oncology
CAPECITABINE for Metastatic colorectal cancer | Advanced colorectal cancer
Phase III trial of CAPECITABINE for Metastatic colorectal cancer | Advanced colorectal cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic colorectal cancer | Advanced colorectal cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-03-2024
- First CTIS Authorization Date
- 17-05-2024
Trial design
Randomised, open-label, four randomized arms: fluoropyrimidine monotherapy, full dose (standard dosage) vs fluoropyrimidine monotherapy, upfront dose-reduced (upfront reduction of 25% [75% of standard dosage]); fluoropyrimidine + oxaliplatin, full dose (standard dosage) vs fluoropyrimidine + oxaliplatin, upfront dose-reduced (upfront reduction of 25% [75% of standard dosage]). specific mg/m2 dosing not stated in arm descriptions.-controlled Phase III trial in Netherlands.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Four randomized arms: Fluoropyrimidine monotherapy, full dose (standard dosage) vs Fluoropyrimidine monotherapy, upfront dose-reduced (Upfront reduction of 25% [75% of standard dosage]); Fluoropyrimidine + oxaliplatin, full dose (standard dosage) vs Fluoropyrimidine + oxaliplatin, upfront dose-reduced (Upfront reduction of 25% [75% of standard dosage]). Specific mg/m2 dosing not stated in arm descriptions.
- Target Sample Size
- 587
Stratification factors
- Mono-chemotherapy versus doublet chemotherapy (stratification based on individual risk of toxicity)
Eligibility
Recruits 587 Vulnerable population not selected. The trial requires written informed consent and excludes "Patients with severe cognitive deficits making informed consent not possible". Participants must be able to understand the Dutch language (language requirement). Consent is provided by the adult participant (no pediatric/assent procedures described)..
- Vulnerable Population
- Vulnerable population not selected. The trial requires written informed consent and excludes "Patients with severe cognitive deficits making informed consent not possible". Participants must be able to understand the Dutch language (language requirement). Consent is provided by the adult participant (no pediatric/assent procedures described).
Inclusion criteria
- {"criterion_text":"- Patients aged 70 years or older with colorectal cancer and distant metastases without localized treatment options."}
- {"criterion_text":"- Patients who are candidates for first-line palliative chemotherapy as judged by their treating oncologist"}
- {"criterion_text":"- Being able to understand the Dutch language"}
- {"criterion_text":"- Written informed consent"}
- {"criterion_text":"- Adequate bone marrow and organ function as defined by following laboratory values: Absolute neutrophil count (ANC) > 1.5 x 10^9 mmol/L, Hemoglobin (Hb) > 6.0 mmol/L, Platelets >100 x 109 / L, Serum bilirubin ≤ 2 x upper limit of normal (ULN), serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases."}
Exclusion criteria
- {"criterion_text":"- Patients who received prior palliative chemotherapy"}
- {"criterion_text":"- Patients in whom local treatment of metastases with curative intent is scheduled (i.e. liver surgery or stereotactic radiotherapy)"}
- {"criterion_text":"- Patients who received prior adjuvant chemotherapy in the one year before inclusion in the study (chemotherapy before that time is allowed)"}
- {"criterion_text":"- Patients with complete or incomplete dihydropyrimidine dehydrogenase (DPD) deficiency"}
- {"criterion_text":"- Patients with Microsatellite instable (MSI)-high colorectal cancer"}
- {"criterion_text":"- Patients with known HIV or active hepatitis infection"}
- {"criterion_text":"- Patients with severe kidney failure (defined as GFR ≤30ml/min)"}
- {"criterion_text":"- Patients with severe cognitive deficits making informed consent not possible"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-free survival","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Quality of Life","definition_or_measurement_approach":""}
- {"endpoint_text":"- Physical Functioning","definition_or_measurement_approach":""}
- {"endpoint_text":"- Grade 3-5 chemotherapy-related toxicity","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall Survival","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of completed treatment cycles","definition_or_measurement_approach":""}
- {"endpoint_text":"- Dose reductions during treatment","definition_or_measurement_approach":""}
- {"endpoint_text":"- Unplanned hospitalizations","definition_or_measurement_approach":""}
- {"endpoint_text":"- Cumulative received dosage","definition_or_measurement_approach":""}
- {"endpoint_text":"- Cost-effectiveness","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 587
- Recruitment Window Months
- 54
- Consent Approach
- Written informed consent is required from each participant. Participants must be able to understand the Dutch language. Subject information and informed consent forms for adults are provided (documents listed). No pediatric assent procedures described.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 587
Netherlands
- Earliest CTIS Part Ii Submission Date
- 29-04-2024
- Latest Decision Or Authorization Date
- 31-03-2025
- Processing Time Days
- 336
- Number Of Sites
- 40
- Number Of Participants
- 587
Sites
- Site Name
- Laurentius Ziekenhuis Roermond
- Department Name
- Oncologie
- Contact Person Name
- Loes Verhoeven
- Contact Person Email
- loes.verhoeven@lzr.nl
- Site Name
- Stichting Viecuri Medisch Centrum voor Noord-Limburg
- Department Name
- Interne geneeskunde oncologie
- Contact Person Name
- H. Vestjens
- Contact Person Email
- hvestjens@viecuri.nl
- Site Name
- Medisch Centrum Leeuwarden B.V.
- Department Name
- Polikliniek en Dagcentrum OCL
- Contact Person Name
- J.A.J. Douma
- Contact Person Email
- Wetenschap@mclacademie.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Medische Oncologie
- Contact Person Name
- K. Versteeg
- Contact Person Email
- k.versteeg@amsterdamumc.nl
- Site Name
- Sint Franciscus Vlietland Groep Stichting
- Department Name
- Oncologie
- Contact Person Name
- Danielle Mathijssen-van Stein
- Contact Person Email
- d.mathijssen-vanstein@franciscus.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Oncologie
- Contact Person Name
- R.T. Lugtenberg
- Contact Person Email
- r.t.lugtenberg@isala.nl
- Site Name
- Noordwest Ziekenhuisgroep Stichting
- Department Name
- Oncologie
- Contact Person Name
- I.G.C. Hermsen
- Contact Person Email
- igc.hermsen@nwz.nl
- Site Name
- Medisch Spectrum Twente
- Department Name
- Oncologie
- Contact Person Name
- A.N.M. Wymenga
- Contact Person Email
- A.Wymenga@mst.nl
- Site Name
- Ziekenhuis Amstelland
- Department Name
- Oncologie
- Contact Person Name
- A. van Zweeden
- Contact Person Email
- a.vanzweeden@zha.nl
- Site Name
- Catharina Ziekenhuis Stichting
- Department Name
- Oncologie
- Contact Person Name
- I.E.G. van Hellemond
- Contact Person Email
- irene.v.hellemond@catharinaziekenhuis.nl
- Site Name
- ZorgSaam Ziekenhuis
- Department Name
- Oncologie
- Contact Person Name
- M.A. van Dijk
- Contact Person Email
- m.vandijk@zzv.nl
- Site Name
- Diakonessenhuis Stichting
- Department Name
- Interne Oncologie
- Contact Person Name
- T. Oostergo
- Contact Person Email
- wetenschapsbureau@diakhuis.nl
- Site Name
- Wilhelmina Ziekenhuis Assen
- Department Name
- Inwendige geneeskunde, interne oncologie
- Contact Person Name
- Titia Lamberts
- Contact Person Email
- researchbureau@wza.nl
- Site Name
- Meander Medisch Centrum
- Department Name
- Oncologie
- Contact Person Name
- Hans-Martin Otten
- Contact Person Email
- jmmb.otten@meandermc.nl
- Site Name
- Admiraal De Ruyter Ziekenhuis B.V.
- Department Name
- Interne Geneeskunde/oncologie
- Contact Person Name
- H. van Halteren
- Contact Person Email
- hk.vanhalteren@adrz.nl
- Site Name
- Elkerliek Ziekenhuis
- Department Name
- Interne Geneeskunde - Hemato-oncologie
- Contact Person Name
- M.M. Teeuwen - van Genderen
- Contact Person Email
- mm.vangenderen@elkerliek.nl
- Site Name
- Ziekenhuis St Jansdal
- Department Name
- Interne Geneeskunde
- Contact Person Name
- J.A. Ropela
- Contact Person Email
- ja.ropela@stjansdal.nl
- Site Name
- Ziekenhuis Gelderse Vallei Stichting
- Department Name
- Oncologisch Centrum
- Contact Person Name
- A. Baars
- Contact Person Email
- BaarsA@zgv.nl
- Site Name
- Deventer Ziekenhuis
- Department Name
- Oncologie
- Contact Person Name
- Lonneke Kessels
- Contact Person Email
- L.Kessels@dz.nl
- Site Name
- Ziekenhuisgroep Twente Stichting
- Department Name
- Interne Geneeskunde
- Contact Person Name
- R de Jong- Wever
- Contact Person Email
- J.Coes@zgt.nl
- Site Name
- Alrijne Zorggroep Stichting
- Department Name
- Medische Oncologie
- Contact Person Name
- L. Spierings
- Contact Person Email
- leaspierings@alrijne.nl
- Site Name
- Haga Hospital
- Department Name
- Medische Oncologie
- Contact Person Name
- D. Houtsma
- Contact Person Email
- d.houtsma@hagaziekenhuis.nl
- Site Name
- Jeroen Bosch Ziekenhuis
- Department Name
- Oncologie
- Contact Person Name
- H. Pruijt
- Contact Person Email
- H.Pruijt@jbz.nl
- Site Name
- Rode Kruis Ziekenhuis B.V.
- Department Name
- Interne Geneeskunde
- Contact Person Name
- A. Goosens
- Contact Person Email
- agoosens@rkz.nl
- Site Name
- Treant Ziekenhuiszorg Stichting
- Department Name
- Interne Geneeskunde
- Contact Person Name
- M. Tent
- Contact Person Email
- m.tent@treant.nl
- Site Name
- Sint Antonius Ziekenhuis Stichting
- Department Name
- Interne Geneeskunde
- Contact Person Name
- M. Los
- Contact Person Email
- m.los@antoniusziekenhuis.nl
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Medische Oncologie
- Contact Person Name
- Inge Werter
- Contact Person Email
- iwerter@rijnstate.nl
- Site Name
- Streekziekenhuis Koningin Beatrix
- Department Name
- Oncologie/poli Interne
- Contact Person Name
- M. Duizer
- Contact Person Email
- m.duizer@skbwinterswijk.nl
- Site Name
- Tergooiziekenhuizen
- Department Name
- Interne Geneeskunde
- Contact Person Name
- A. van der Velden
- Contact Person Email
- avandervelden@tergooi.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Medical Oncology
- Contact Person Name
- Johanneke Portielje
- Contact Person Email
- J.E.A.Portielje@lumc.nl
- Site Name
- Reinier de Graaf Groep
- Department Name
- Research Unit Oncology
- Contact Person Name
- Arjan Verschoor
- Contact Person Email
- wetenschapsbureau@rdgg.nl
- Site Name
- Ommelander Ziekenhuis Groningen B.V.
- Department Name
- Medische Oncologie
- Contact Person Name
- T. Osinga
- Contact Person Email
- t.osinga@ozg.nl
- Site Name
- Bravis Ziekenhuis
- Department Name
- Oncologie
- Contact Person Name
- F Terheggen
- Contact Person Email
- f.terheggen@bravis.nl
- Site Name
- Medical Center Haaglanden
- Department Name
- Oncologie
- Contact Person Name
- A. Jochems
- Contact Person Email
- a.jochems@haaglandenmc.nl
- Site Name
- Canisius Wilhelmina Ziekenhuis
- Department Name
- Oncologie
- Contact Person Name
- Johan Janssen
- Contact Person Email
- Johan.janssen@cwz.nl
- Site Name
- Spaarne Gasthuis Stichting
- Department Name
- Oncologie
- Contact Person Name
- J. Schrama
- Contact Person Email
- jschrama@spaarnegasthuis.nl
- Site Name
- Bernhoven B.V.
- Department Name
- Interne Geneeskunde
- Contact Person Name
- M. Janssen
- Contact Person Email
- mar.janssen@bernhoven.nl
- Site Name
- Beatrix Ziekenhuis
- Department Name
- Interne oncologie
- Contact Person Name
- M.A. Davidis
- Contact Person Email
- m.davidis@rivas.nl
- Site Name
- Maxima Medisch Centrum
- Department Name
- Oncologie
- Contact Person Name
- Lieke Simkens
- Contact Person Email
- l.simkens@mmc.nl
- Site Name
- Slingeland Ziekenhuis
- Department Name
- Interne Geneeskunde
- Contact Person Name
- C. van Arkel
- Contact Person Email
- c.van.arkel@slingeland.nl
- Site Name
- Maasstad Ziekenhuis Stichting
- Department Name
- Oncologie
- Contact Person Name
- B.C.M. Haberkorn
- Contact Person Email
- HaberkornB@maasstadziekenhuis.nl
- Site Name
- Zaans Medisch Centrum Stichting
- Department Name
- Oncologie
- Contact Person Name
- A.S.B. Conijn
- Contact Person Email
- Conijn.A@zaansmc.nl
- Site Name
- Ikazia Ziekenhuis
- Department Name
- Oncologie
- Contact Person Name
- F.E. de Jongh
- Contact Person Email
- fe.de.jongh@ikazia.nl
- Site Name
- Groene Hart Ziekenhuis
- Department Name
- Medische Oncologie
- Contact Person Name
- Marissa Cloos-van Baalen
- Contact Person Email
- Marissa.Cloos@ghz.nl
- Site Name
- IJsselland Ziekenhuis
- Department Name
- Oncologie
- Contact Person Name
- Laura Poppe-Manenschijn
- Contact Person Email
- dkehrer@ysl.nl
Sponsor
Primary sponsor
- Full Name
- Academisch Ziekenhuis Leiden
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Capecitabine 500 mg Film-coated Tablets
- Active Substance
- CAPECITABINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 1000 mg/m2 per day
- Investigational Product Name
- Fluorouracil 50 mg/ml Solution for injection/infusion
- Active Substance
- FLUOROURACIL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 1200 mg/m2 per day
- Investigational Product Name
- Calcium Folinate 10 mg/ml Solution for injection or infusion
- Active Substance
- FOLINIC ACID
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 400 mg/m2 per day
- Investigational Product Name
- Oxaliplatin 5 mg/ml Concentrate for Solution for infusion
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 130 mg/m2 per day
- Combination Treatment
- Yes
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