Multicentric Randomised Trial for Resectable Gastric Cancer
NCT ID: NCT02931890
Last Updated: 2024-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
207 participants
INTERVENTIONAL
2017-12-21
2029-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Preoperative treatment is associated with better patient compliance than postoperative regimens
* Preoperative treatment increases the likelihood of disease downsizing/downstaging and radical R0 resections
* Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC chemotherapy are effective, feasible and safe regimens
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
NCT01517009
Randomized Phase III Trial of Adjuvant Chemotherapy or Chemoradiotherapy in Resectable Gastric Cancer (CRITICS)
NCT00407186
Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis
NCT02380131
Pre-Operative Or Peri-Operative Dox Regimen In Patients With Locally Advanced Resectable Gastric Cancer
NCT01876927
Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction and Gastric Cancers
NCT05296005
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
neo-adjuvant chemotherapy followed by surgery
4 courses of 3 weekly DOC followed by surgery
Docetaxel
3 weekly course of docetaxel i.v in arm 1 and 2
Oxaliplatin
3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2
Capecitabine
oral capecitabine in arm 1 and 2
gastrectomy
resection of gastric cancer after pre-operative chemotherapy for all arms
neo-adjuvant chemo and subsequent CRT followed by surgery
2 courses of 3 weekly DOC and subsequent CRT followed by surgery
Docetaxel
3 weekly course of docetaxel i.v in arm 1 and 2
Oxaliplatin
3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2
Capecitabine
oral capecitabine in arm 1 and 2
gastrectomy
resection of gastric cancer after pre-operative chemotherapy for all arms
radiotherapy of gastric cancer
5 weeks of radiation, 5 times a week with a total of 45 Gy (in arm 2 and 3)
Paclitaxel
5 weeks of paclitaxel i.v once a week (in arm 2 and 3)
Carboplatin
5 weeks of carboplatin i.v once a week (in arm 2 and 3)
neo-adjuvant chemoradiotherapy followed by surgery
chemoradiotherapy followed by surgery
gastrectomy
resection of gastric cancer after pre-operative chemotherapy for all arms
radiotherapy of gastric cancer
5 weeks of radiation, 5 times a week with a total of 45 Gy (in arm 2 and 3)
Paclitaxel
5 weeks of paclitaxel i.v once a week (in arm 2 and 3)
Carboplatin
5 weeks of carboplatin i.v once a week (in arm 2 and 3)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Docetaxel
3 weekly course of docetaxel i.v in arm 1 and 2
Oxaliplatin
3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2
Capecitabine
oral capecitabine in arm 1 and 2
gastrectomy
resection of gastric cancer after pre-operative chemotherapy for all arms
radiotherapy of gastric cancer
5 weeks of radiation, 5 times a week with a total of 45 Gy (in arm 2 and 3)
Paclitaxel
5 weeks of paclitaxel i.v once a week (in arm 2 and 3)
Carboplatin
5 weeks of carboplatin i.v once a week (in arm 2 and 3)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* WHO \< 2
* Age ≥ 18 yrs
* Resectable adenocarcinoma of the stomach or gastro-oesophageal junction
* No prior abdominal radiotherapy
* Haematology: Hb ≥5.0 mmol/l; leukocytes≥3.0x109/l, neutrophils ≥1.5x109/l, thrombocytes ≥100x109/l
* Renal function: serum creatinine ≤1.25x ULN, creatinine clearance ≥ 50 ml/min (calculated by Cockcroft and Gault formula) Liver function: total bilirubin ≤1.5x ULN, alkaline phosphatase and ASAT/ALAT ≤ 3x ULN
* At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesions and/or substantial free peritoneal fluid if any should be pathologically proven tumor negative
* Written informed consent
* Expected adequacy of follow-up
* 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
Exclusion Criteria
* Distant metastases
* Inoperable patients; due to technical surgery-related factors or general condition
* 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 after consultation of the principal investigator
* Solitary functioning kidney that will be within the radiation field
* Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery
* Uncontrolled (bacterial) infections
* Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
* Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias
* Continuous use of immunosuppressive agents equivalent to \>10 mg daily prednison
* Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
* Neurotoxicity \> CTC grade 1
* Pregnancy or breast feeding
* Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
* Gastric or gastro-esophageal stent within radiation field
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Netherlands Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marcel Verheij, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zuyderland Medisch Centrum
Sittard-Geleen, Limburg, Netherlands
Viecuri Medisch Centrum
Venlo, Limburg, Netherlands
Elkerliek
Deurne, North Brabant, Netherlands
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Maxima Medisch Centrum
Eindhoven, North Brabant, Netherlands
St. Anna Zorggroep
Geldrop, North Brabant, Netherlands
Elkerliek
Helmond, North Brabant, Netherlands
Instituut Verbeeten
Tilburg, North Brabant, Netherlands
Bernhoven
Uden, North Brabant, Netherlands
Maxima Medisch Centrum
Veldhoven, North Brabant, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
Ziekenhuisgroep Twente
Almelo, Overijssel, Netherlands
Deventer Ziekenhuis
Deventer, Overijssel, Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
Radiotherapeutisch Instituut Friesland
Leeuwarden, Provincie Friesland, Netherlands
Reinier de Graaf Gasthuis
Delft, South Holland, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Netherlands Cancer Instituut
Amsterdam, , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Rijnstate
Arnhem, , Netherlands
Ziekenhuis Gelderse Vallei
Ede, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Ziekenhuis St Antonius
Nieuwegein, , Netherlands
HAGA ziekenhuis
The Hague, , Netherlands
Elisabeth Tweesteden Ziekenhuis
Tilburg, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Slagter AE, Jansen EPM, van Laarhoven HWM, van Sandick JW, van Grieken NCT, Sikorska K, Cats A, Muller-Timmermans P, Hulshof MCCM, Boot H, Los M, Beerepoot LV, Peters FPJ, Hospers GAP, van Etten B, Hartgrink HH, van Berge Henegouwen MI, Nieuwenhuijzen GAP, van Hillegersberg R, van der Peet DL, Grabsch HI, Verheij M. CRITICS-II: a multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer. BMC Cancer. 2018 Sep 10;18(1):877. doi: 10.1186/s12885-018-4770-2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL 55436.031.015
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-004627-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15CRI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.