Clinical trial • Phase IV • Oncology
CAPECITABINE for Gastric adenocarcinoma (resectable, stage IB–IIC)
Phase IV trial of CAPECITABINE for Gastric adenocarcinoma (resectable, stage IB–IIC).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Gastric adenocarcinoma (resectable, stage IB–IIC)
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-06-2024
- First CTIS Authorization Date
- 18-06-2024
Trial design
Randomised, open-label, three-arm comparison: (1) neo-adjuvant chemotherapy followed by surgery; (2) neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery; (3) neo-adjuvant chemoradiotherapy followed by surgery. (no drug doses or schedules specified in the ctis record provided.)-controlled Phase IV trial across 28 sites in Netherlands.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Three-arm comparison: (1) neo-adjuvant chemotherapy followed by surgery; (2) neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery; (3) neo-adjuvant chemoradiotherapy followed by surgery. (No drug doses or schedules specified in the CTIS record provided.)
- Target Sample Size
- 207
- Trial Duration For Participant
- 365
Eligibility
Recruits 207 No vulnerable populations selected; participants must be ≥ 18 years and provide written informed consent. No assent or parental consent described..
- Pregnancy Exclusion
- Pregnancy or breast feeding
- Vulnerable Population
- No vulnerable populations selected; participants must be ≥ 18 years and provide written informed consent. No assent or parental consent described.
Inclusion criteria
- {"criterion_text":"- TNM 8th ed IB- IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involvegastro-oesophageal junction\n- Start treatment within 15 working days after randomisation\n- Written informed consent\n- Expected adequacy of follow-up\n- Caloric intake ≥ 1500 kcal/day, verified by a dietician before registration. -- if caloric intake is < 1500 kcal/day or if bodyweight has decreased > 10% over the last 6 months or > 5% over the last month, dietary intervention such as oral nutritional support or enteral tube feeding is mandatory\n- WHO < 2\n- Age ≥ 18 yrs\n- Resectable adenocarcinoma of the stomach or gastro-oesophageal junction\n- No prior abdominal radiotherapy\n- Haematology: Hb ≥ 5.0 mmol/l; leukocytes ≥ 3.0x109/l, neutrophils ≥ 1.5x109/l, thrombocytes ≥ 100x109/l\n- Renal function: serum creatinine ≤ 1.25x ULN, creatinine clearance ≥ 50 ml/min (calculated by Cockcroft and Gault formula)\n- Liver function: total bilirubin ≤ 1.5x ULN, alkaline phosphatase and ASAT/ALAT ≤ 3x ULN\n- At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesions and/or substantial freeperitoneal fluid if any should be pathologically proven tumor negative"}
Exclusion criteria
- {"criterion_text":"- T1N0 disease endoscopic ultrasound\n- Continuous use of immunosuppressive agents equivalent to >10 mg daily prednison\n- Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine\n- Neurotoxicity > CTC grade 1\n- Pregnancy or breast feeding\n- Patients (M/F) with reproductive potential not implementing adequate contraceptive measures\n- Gastric or gastro-esophageal stent within radiation field\n- Distant metastases\n- Irresectable patients; due to technical surgery-related factors or general condition\n- Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri;in case of a previous other malignancy with a disease-free period ≥ 5 years, inclusion can be accepted afterconsultation of the principal investigator\n- Solitary functioning kidney that will be within the radiation field\n- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of majorsurgery\n- Uncontrolled (bacterial) infections\n- Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments\n- Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Event‐free survival at 1 year after randomisation (events: local recurrence, regional recurrence, local‐regional recurrence or progression, distant recurrence, or death from any cause).","definition_or_measurement_approach":"Event-free survival at 1 year after randomisation; events defined as local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence, or death from any cause."}
Other endpoints
- {"endpoint_text":"- To assess time to event of all treatment arms\n- To assess which preoperative regimen provides superior time-to-recurrence (TTR)\n- To assess which preoperative regimen is most feasible, based on toxicity, pCR and R0 resection rates\n- To assess the toxicity profile of all treatment arms\n- To document surgical morbidity, including incidence of anastomotic leakage\n- To determine the pCR rates of all treatment arms\n- To determine the R0 resection rates of all treatment arms\n- To determine the response rate (RR) of all treatment arms\n- To determine the OS of all treatment arms\n- To identify which preoperative regimen (CRITICS-II) will be compared with the new standard treatment (CRITICS-I) in a nextphase III trial","definition_or_measurement_approach":"Most items are stated as objectives without detailed measurement methods in the provided record. \"Time to event\" and TTR are time-to-event endpoints; pCR rates, R0 resection rates, response rate (RR) and overall survival (OS) are standard clinical endpoints measured per pathology/survival/response assessments. Toxicity profile assessed by toxicity assessments (not further specified). Surgical morbidity documented including incidence of anastomotic leakage (not further specified)."}
Recruitment
- Planned Sample Size
- 207
- Recruitment Window Months
- 128
- Consent Approach
- Written informed consent required. Participants must be ≥18 years and provide written informed consent. Subject information and informed consent form documents (L1) are listed in the CTIS documents. Languages of consent documents not specified.
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 207
Netherlands
- Latest Decision Or Authorization Date
- 22-12-2025
- Number Of Sites
- 28
- Number Of Participants
- 207
Sites
- Site Name
- Spaarne Gasthuis
- Department Name
- Medical oncology
- Principal Investigator Name
- A. Beeker
- Principal Investigator Email
- WetenschapsBureau@spaarnegasthuis.nl
- Contact Person Name
- A. Beeker
- Contact Person Email
- WetenschapsBureau@spaarnegasthuis.nl
- Site Name
- Elkerliek Ziekenhuis
- Department Name
- Medical oncology
- Principal Investigator Name
- J. Vincent
- Principal Investigator Email
- npjw.vandekerkhof@elkerliek.nl
- Contact Person Name
- J. Vincent
- Contact Person Email
- npjw.vandekerkhof@elkerliek.nl
- Site Name
- Medisch Spectrum Twente
- Department Name
- Medical oncology
- Principal Investigator Name
- J.M. Postel-Mekenkamp
- Principal Investigator Email
- ResearchOC@mst.nl
- Contact Person Name
- J.M. Postel-Mekenkamp
- Contact Person Email
- ResearchOC@mst.nl
- Site Name
- Radiotherapiegroep
- Department Name
- Radiotherapy
- Principal Investigator Name
- K. Muller
- Principal Investigator Email
- trial@radiotherapiegroep.nl
- Contact Person Name
- K. Muller
- Contact Person Email
- trial@radiotherapiegroep.nl
- Site Name
- Stichting Sint Antonius Ziekenhuis
- Department Name
- Medical oncology
- Principal Investigator Name
- M. Los
- Principal Investigator Email
- m.los@antoniusziekenhuis.nl
- Contact Person Name
- M. Los
- Contact Person Email
- m.los@antoniusziekenhuis.nl
- Site Name
- Stichting Ziekenhuis Gelderse Vallei
- Department Name
- Medical oncology
- Principal Investigator Name
- M.C.H.M. Verstappen
- Principal Investigator Email
- polioncologie@zgv.nl
- Contact Person Name
- M.C.H.M. Verstappen
- Contact Person Email
- polioncologie@zgv.nl
- Site Name
- Medisch Centrum Leeuwarden B.V.
- Department Name
- Medical oncology
- Principal Investigator Name
- M.B. Polee
- Principal Investigator Email
- Wetenschap@mclacademie.nl
- Contact Person Name
- M.B. Polee
- Contact Person Email
- Wetenschap@mclacademie.nl
- Site Name
- Stichting VU
- Department Name
- Medical oncology
- Principal Investigator Name
- H.W.M. van Laarhoven
- Principal Investigator Email
- h.vanlaarhoven@amsterdamumc.nl
- Contact Person Name
- H.W.M. van Laarhoven
- Contact Person Email
- h.vanlaarhoven@amsterdamumc.nl
- Site Name
- Maastro Clinic
- Department Name
- Radiotherapy
- Principal Investigator Name
- J. Buijsen
- Principal Investigator Email
- jeroen.buijsen@maastro.nl
- Contact Person Name
- J. Buijsen
- Contact Person Email
- jeroen.buijsen@maastro.nl
- Site Name
- University Medical Center Groningen
- Department Name
- Surgery
- Principal Investigator Name
- B. van Etten
- Principal Investigator Email
- b.van.etten@umcg.nl
- Contact Person Name
- B. van Etten
- Contact Person Email
- b.van.etten@umcg.nl
- Site Name
- Stichting Catharina Ziekenhuis
- Department Name
- Surgery
- Principal Investigator Name
- G.A.P. Nieuwenhuijzen
- Principal Investigator Email
- achgnn@cze.nl
- Contact Person Name
- G.A.P. Nieuwenhuijzen
- Contact Person Email
- achgnn@cze.nl
- Site Name
- Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis
- Department Name
- surgery
- Principal Investigator Name
- J.W. van Sandick
- Principal Investigator Email
- j.v.sandick@nki.nl
- Contact Person Name
- J.W. van Sandick
- Contact Person Email
- j.v.sandick@nki.nl
- Site Name
- Stichting Zuyderland Medisch Centrum
- Department Name
- Medical oncology
- Principal Investigator Name
- F.A.R.M. Warmerdam
- Principal Investigator Email
- bwo@zuyderland.nl
- Contact Person Name
- F.A.R.M. Warmerdam
- Contact Person Email
- bwo@zuyderland.nl
- Site Name
- Leiden University Medical Center
- Department Name
- Surgery
- Principal Investigator Name
- H.H. Hartgrink
- Principal Investigator Email
- h.h.hartgrink@lumc.nl
- Contact Person Name
- H.H. Hartgrink
- Contact Person Email
- h.h.hartgrink@lumc.nl
- Site Name
- Sint Anna ziekenhuis
- Principal Investigator Name
- J.M.W.E. Willems
- Principal Investigator Email
- research.oncologie@st-anna.nl
- Contact Person Name
- J.M.W.E. Willems
- Contact Person Email
- research.oncologie@st-anna.nl
- Site Name
- Reinier De Graaf
- Department Name
- Medical oncology
- Principal Investigator Name
- A.J.E. Vulink
- Principal Investigator Email
- cardiore@rdgg.nl
- Contact Person Name
- A.J.E. Vulink
- Contact Person Email
- cardiore@rdgg.nl
- Site Name
- Jeroen Bosch Ziekenhuis
- Department Name
- Medical oncology
- Principal Investigator Name
- J. Tol
- Principal Investigator Email
- j.tol@jbz.nl
- Contact Person Name
- J. Tol
- Contact Person Email
- j.tol@jbz.nl
- Site Name
- Stichting Rijnstate Ziekenhuis
- Department Name
- Medical oncology
- Principal Investigator Name
- T. van Voorthuizen
- Principal Investigator Email
- tvanvoorthuizen@rijnstate.nl
- Contact Person Name
- T. van Voorthuizen
- Contact Person Email
- tvanvoorthuizen@rijnstate.nl
- Site Name
- Academisch Medisch Centrum
- Department Name
- Oncology
- Principal Investigator Name
- H.W.M. van Laarhoven
- Principal Investigator Email
- h.vanlaarhoven@amsterdamumc.nl
- Contact Person Name
- H.W.M. van Laarhoven
- Contact Person Email
- h.vanlaarhoven@amsterdamumc.nl
- Site Name
- Maxima Medisch Centrum
- Department Name
- Medical oncology
- Principal Investigator Name
- L.H.J Simkens
- Principal Investigator Email
- lokaleuitvoerbaarheid@mmc.nl
- Contact Person Name
- L.H.J Simkens
- Contact Person Email
- lokaleuitvoerbaarheid@mmc.nl
- Site Name
- Stichting Viecuri Medisch Centrum voor Noord-Limburg
- Department Name
- Medical oncology
- Principal Investigator Name
- E. Boon
- Principal Investigator Email
- elineboon@viecuri.nl
- Contact Person Name
- E. Boon
- Contact Person Email
- elineboon@viecuri.nl
- Site Name
- Deventer Ziekenhuis
- Department Name
- Medical oncology
- Principal Investigator Name
- L.W. Kessels
- Principal Investigator Email
- wetenschapsbureau@dz.nl
- Contact Person Name
- L.W. Kessels
- Contact Person Email
- wetenschapsbureau@dz.nl
- Site Name
- Radiotherapeutisch Instituut Friesland
- Department Name
- Radiotherapy
- Principal Investigator Name
- V. Oppedijk
- Principal Investigator Email
- datamanager@skf-rif.nl
- Contact Person Name
- V. Oppedijk
- Contact Person Email
- datamanager@skf-rif.nl
- Site Name
- Stichting Ziekenhuisgroep Twente
- Department Name
- Interne geneeskunde
- Principal Investigator Name
- R. Hoekstra
- Principal Investigator Email
- r.hoekstra@zgt.nl
- Contact Person Name
- R. Hoekstra
- Contact Person Email
- r.hoekstra@zgt.nl
- Site Name
- University Medical Center Utrecht
- Department Name
- Surgery
- Principal Investigator Name
- R. van Hillegersberg
- Principal Investigator Email
- r.vanhillegersberg@umcutrecht.nl
- Contact Person Name
- R. van Hillegersberg
- Contact Person Email
- r.vanhillegersberg@umcutrecht.nl
- Site Name
- Bernhoven B.V.
- Department Name
- Medical oncology
- Principal Investigator Name
- A.H. Vos
- Principal Investigator Email
- cm-onco@bernhoven.nl
- Contact Person Name
- A.H. Vos
- Contact Person Email
- cm-onco@bernhoven.nl
- Site Name
- Elisabeth-TweeSteden Ziekenhuis
- Department Name
- Medical oncology
- Principal Investigator Name
- L.V. Beerepoot
- Principal Investigator Email
- rvalphen@tsz.nl
- Contact Person Name
- L.V. Beerepoot
- Contact Person Email
- rvalphen@tsz.nl
- Site Name
- Instituut Verbeeten
- Department Name
- radiotherapy
- Principal Investigator Name
- T. Rozema
- Principal Investigator Email
- Wetenschapscommissie@bvi.nl
- Contact Person Name
- T. Rozema
- Contact Person Email
- Wetenschapscommissie@bvi.nl
Sponsor
Primary sponsor
- Full Name
- Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- CAPECITABINE
- Active Substance
- CAPECITABINE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Maximum Dose
- 850 mg/m2
- Investigational Product Name
- OXALIPLATIN
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- 100 mg/m2
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- 2 (unit not specified)
- Investigational Product Name
- PACLITAXEL
- Active Substance
- PACLITAXEL
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- 50 mg/m2
- Investigational Product Name
- DOCETAXEL
- Active Substance
- DOCETAXEL
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- 50 mg/m2
- Combination Treatment
- Yes
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