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Gastric CancerPhase 2CRITICS-IINCT02931890

Multicentric Randomised Trial for Resectable Gastric Cancer

A Phase 2 study testing Docetaxel, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by The Netherlands Cancer Institute at 28 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Docetaxel, Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
28 sitesNetherlands
Study dates
21 Dec 2017to Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • TNM 8th ed stage IB-IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction
  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • T1N0 disease (assessed by endoscopic ultrasound)
  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Netherlands28 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Ziekenhuisgroep Twente

    Almelo, Overijssel, 7609 PP

  • Netherlands Cancer Instituut

    Amsterdam, 1066CX

  • Academisch Medisch Centrum

    Amsterdam, 1105AZ

  • Rijnstate

    Arnhem, 6815AD

  • Reinier de Graaf Gasthuis

    Delft, South Holland, 2625 AD

  • Elkerliek

    Deurne, North Brabant, 5751 CB

  • Deventer Ziekenhuis

    Deventer, Overijssel, 7416 SE

  • Ziekenhuis Gelderse Vallei

    Ede, 6716RP

  • Catharina Ziekenhuis

    Eindhoven, North Brabant, 5602 ZA

  • Maxima Medisch Centrum

    Eindhoven, North Brabant, 5631 BM

  • Medisch Spectrum Twente

    Enschede, Overijssel, 7512 KZ

  • St. Anna Zorggroep

    Geldrop, North Brabant, 5664 EH

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Elkerliek

    Helmond, North Brabant, 5707 HA

  • Spaarne Gasthuis

    Hoofddorp, North Holland, 2000 AK

  • Medisch Centrum Leeuwarden

    Leeuwarden, Provincie Friesland, 8901BR

  • Radiotherapeutisch Instituut Friesland

    Leeuwarden, Provincie Friesland, 8934AD

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA

  • Ziekenhuis St Antonius

    Nieuwegein, 3435CM

  • Zuyderland Medisch Centrum

    Sittard-Geleen, Limburg, 6162 BG

  • HAGA ziekenhuis

    The Hague, 2545AA

  • Instituut Verbeeten

    Tilburg, North Brabant, 5022 GC

  • Elisabeth Tweesteden Ziekenhuis

    Tilburg, 5022GC

  • Bernhoven

    Uden, North Brabant, 5406 PT

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3508 GA

  • Maxima Medisch Centrum

    Veldhoven, North Brabant, 5504 DB

  • Viecuri Medisch Centrum

    Venlo, Limburg, 5912 BL

Other trials in Netherlands

About this study

Official title: A Multicentre Randomised Phase II Trial of Neo-adjuvant Chemotherapy Followed by Surgery vs. Neo-adjuvant Chemotherapy and Subsequent Chemoradiotherapy Followed by Surgery vs. Neo-adjuvant Chemoradiotherapy Followed by Surgery in Resectable Gastric Cancer

The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is based on the following concepts:

  • 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
Conditions
Gastric Cancer
Being tested
Docetaxel, Oxaliplatin, Capecitabine, gastrectomy, radiotherapy of gastric cancer
Keywords
gastric cancer, radiotherapy, chemoradiotherapy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere

    3 weekly course of docetaxel i.v in arm 1 and 2

  • OxaliplatinDrug

    Also called Eloxatin

    3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2

  • CapecitabineDrug

    Also called Xeloda

    oral capecitabine in arm 1 and 2

  • gastrectomyProcedure or surgery

    resection of gastric cancer after pre-operative chemotherapy for all arms

  • radiotherapy of gastric cancerRadiation

    5 weeks of radiation, 5 times a week with a total of 45 Gy (in arm 2 and 3)

  • PaclitaxelDrug

    5 weeks of paclitaxel i.v once a week (in arm 2 and 3)

  • CarboplatinDrug

    5 weeks of carboplatin i.v once a week (in arm 2 and 3)

Study groups in NCT02931890
Study groupRoleWhat they receive
neo-adjuvant chemotherapy followed by surgeryActive comparator4 courses of 3 weekly DOC followed by surgery
Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Capecitabine; Procedure: gastrectomy
neo-adjuvant chemo and subsequent CRT followed by surgeryActive comparator2 courses of 3 weekly DOC and subsequent CRT followed by surgery
Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Capecitabine; Procedure: gastrectomy; Radiation: radiotherapy of gastric cancer; Drug: Paclitaxel; Drug: Carboplatin
neo-adjuvant chemoradiotherapy followed by surgeryActive comparatorchemoradiotherapy followed by surgery
Receives: Procedure: gastrectomy; Radiation: radiotherapy of gastric cancer; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-Free survival

    Event-free survival will be measured by clinical outcome and CT-scan

    Measured: 1 year

Secondary outcomes (3)

  1. Time to Event (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence, or death from any cause)

    Interval between randomization and event measured by clinical outcome and CT scan

    Measured: 1 year

  2. Time to recurrence (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence)

    Interval between randomization and recurrence determined by clinical outcome and CT scan

    Measured: 1 year

  3. Toxicity

    Number of patients with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2016 (estimated)
  2. Study start21 Dec 2017
  3. Primary completionApr 2025 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
207 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02931890
Sponsor's protocol ID
M15CRI
Other IDs
NL 55436.031.015, 2015-004627-31, 2015
Acronym
CRITICS-II
Status last verified
Apr 2024
First submitted
14 Sep 2016
Last updated
2 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.

    PubMed 40340830

  • 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.

    PubMed 30200910

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by The Netherlands Cancer Institute at 28 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-Free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02931890, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.

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