Multicentric Randomised Trial for Resectable Gastric Cancer

NCT02931890 | Active Not Recruiting Phase 2

• 3 other identifiers: M15CRINL 55436.031.0152015-004627-31
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 28

Brief 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. 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

Keywords

gastric cancer; radiotherapy; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Event-Free survival

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

  1 year

Secondary Outcomes (3)

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

  1 year

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

  1 year

• Toxicity

  1 year

Study Arms (3)

neo-adjuvant chemotherapy followed by surgery

ACTIVE COMPARATOR

4 courses of 3 weekly DOC followed by surgery

Drug: Docetaxel; Drug: Oxaliplatin; Drug: Capecitabine; Procedure: gastrectomy

neo-adjuvant chemo and subsequent CRT followed by surgery

ACTIVE COMPARATOR

2 courses of 3 weekly DOC and subsequent CRT followed by surgery

Drug: Docetaxel; Drug: Oxaliplatin; Drug: Capecitabine; Procedure: gastrectomy; Radiation: radiotherapy of gastric cancer; Drug: Paclitaxel; Drug: Carboplatin

neo-adjuvant chemoradiotherapy followed by surgery

ACTIVE COMPARATOR

chemoradiotherapy followed by surgery

Procedure: gastrectomy; Radiation: radiotherapy of gastric cancer; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Docetaxel DRUG

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

Also known as: Taxotere

neo-adjuvant chemo and subsequent CRT followed by surgery; neo-adjuvant chemotherapy followed by surgery

Oxaliplatin DRUG

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

Also known as: Eloxatin

neo-adjuvant chemo and subsequent CRT followed by surgery; neo-adjuvant chemotherapy followed by surgery

Capecitabine DRUG

oral capecitabine in arm 1 and 2

Also known as: Xeloda

neo-adjuvant chemo and subsequent CRT followed by surgery; neo-adjuvant chemotherapy followed by surgery

gastrectomy PROCEDURE

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

neo-adjuvant chemo and subsequent CRT followed by surgery; neo-adjuvant chemoradiotherapy followed by surgery; neo-adjuvant chemotherapy followed by surgery

radiotherapy of gastric cancer RADIATION

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

neo-adjuvant chemo and subsequent CRT followed by surgery; neo-adjuvant chemoradiotherapy followed by surgery

Paclitaxel DRUG

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

neo-adjuvant chemo and subsequent CRT followed by surgery; neo-adjuvant chemoradiotherapy followed by surgery

Carboplatin DRUG

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

neo-adjuvant chemo and subsequent CRT followed by surgery; neo-adjuvant chemoradiotherapy followed by surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• T1N0 disease (assessed by endoscopic ultrasound)
• Distant metastases
• Inoperable patients; due to technical surgery-related factors or general condition
• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (28)

Zuyderland Medisch Centrum

Sittard-Geleen, Limburg, 6162 BG, Netherlands

Location

Viecuri Medisch Centrum

Venlo, Limburg, 5912 BL, Netherlands

Location

Elkerliek

Deurne, North Brabant, 5751 CB, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5602 ZA, Netherlands

Location

Maxima Medisch Centrum

Eindhoven, North Brabant, 5631 BM, Netherlands

Location

St. Anna Zorggroep

Geldrop, North Brabant, 5664 EH, Netherlands

Location

Elkerliek

Helmond, North Brabant, 5707 HA, Netherlands

Location

Instituut Verbeeten

Tilburg, North Brabant, 5022 GC, Netherlands

Location

Bernhoven

Uden, North Brabant, 5406 PT, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, North Brabant, 5504 DB, Netherlands

Location

Spaarne Gasthuis

Hoofddorp, North Holland, 2000 AK, Netherlands

Location

Ziekenhuisgroep Twente

Almelo, Overijssel, 7609 PP, Netherlands

Location

Deventer Ziekenhuis

Deventer, Overijssel, 7416 SE, Netherlands

Location

Medisch Spectrum Twente

Enschede, Overijssel, 7512 KZ, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8901BR, Netherlands

Location

Radiotherapeutisch Instituut Friesland

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, South Holland, 2625 AD, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, South Holland, 2333 ZA, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Netherlands Cancer Instituut

Amsterdam, 1066CX, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105AZ, Netherlands

Location

Rijnstate

Arnhem, 6815AD, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, 6716RP, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Ziekenhuis St Antonius

Nieuwegein, 3435CM, Netherlands

Location

HAGA ziekenhuis

The Hague, 2545AA, Netherlands

Location

Elisabeth Tweesteden Ziekenhuis

Tilburg, 5022GC, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3508 GA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 30200910 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Oxaliplatin; Capecitabine; Gastrectomy; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Marcel Verheij, MD, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: October 13, 2016
• Study Start: December 21, 2017
• Primary Completion: April 1, 2025
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (28)