Multicentric Randomised Trial for Resectable Gastric Cancer

Phase 2

Active, not recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: Docetaxel; Drug: Oxaliplatin; Radiation: radiotherapy of gastric cancer; Drug: Capecitabine; Drug: Carboplatin; Procedure: gastrectomy; Drug: Paclitaxel

• Registration Number: NCT02931890
• Lead Sponsor: The Netherlands Cancer Institute

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Study Start: 2017-12-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-04
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• 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

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Exclusion Criteria

• 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
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neo-adjuvant chemoradiotherapy followed by surgery	Carboplatin	chemoradiotherapy followed by surgery
neo-adjuvant chemotherapy followed by surgery	Capecitabine	4 courses of 3 weekly DOC followed by surgery
neo-adjuvant chemotherapy followed by surgery	Oxaliplatin	4 courses of 3 weekly DOC followed by surgery
neo-adjuvant chemotherapy followed by surgery	gastrectomy	4 courses of 3 weekly DOC followed by surgery
neo-adjuvant chemo and subsequent CRT followed by surgery	Docetaxel	2 courses of 3 weekly DOC and subsequent CRT followed by surgery
neo-adjuvant chemo and subsequent CRT followed by surgery	Carboplatin	2 courses of 3 weekly DOC and subsequent CRT followed by surgery
neo-adjuvant chemoradiotherapy followed by surgery	gastrectomy	chemoradiotherapy followed by surgery
neo-adjuvant chemoradiotherapy followed by surgery	radiotherapy of gastric cancer	chemoradiotherapy followed by surgery
neo-adjuvant chemo and subsequent CRT followed by surgery	Oxaliplatin	2 courses of 3 weekly DOC and subsequent CRT followed by surgery
neo-adjuvant chemo and subsequent CRT followed by surgery	radiotherapy of gastric cancer	2 courses of 3 weekly DOC and subsequent CRT followed by surgery
neo-adjuvant chemo and subsequent CRT followed by surgery	gastrectomy	2 courses of 3 weekly DOC and subsequent CRT followed by surgery
neo-adjuvant chemo and subsequent CRT followed by surgery	Paclitaxel	2 courses of 3 weekly DOC and subsequent CRT followed by surgery
neo-adjuvant chemotherapy followed by surgery	Docetaxel	4 courses of 3 weekly DOC followed by surgery
neo-adjuvant chemo and subsequent CRT followed by surgery	Capecitabine	2 courses of 3 weekly DOC and subsequent CRT followed by surgery
neo-adjuvant chemoradiotherapy followed by surgery	Paclitaxel	chemoradiotherapy followed by surgery

Primary Outcome Measures

Name	Time	Method
Event-Free survival	1 year	Event-free survival will be measured by clinical outcome and CT-scan

Secondary Outcome Measures

Name	Time	Method
Time to Event (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence, or death from any cause)	1 year	Interval between randomization and event measured by clinical outcome and CT scan
Time to recurrence (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence)	1 year	Interval between randomization and recurrence determined by clinical outcome and CT scan
Toxicity	1 year	Number of patients with treatment-related adverse events as assessed by CTCAE v4.0

Trial Locations

Locations (26)

Radiotherapeutisch Instituut Friesland; 🇳🇱 Leeuwarden, Friesland, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord Brabant, Netherlands

Maxima Medisch Centrum; 🇳🇱 Veldhoven, Noord Brabant, Netherlands

St. Anna Zorggroep; 🇳🇱 Geldrop, Noord Brabant, Netherlands

Instituut Verbeeten; 🇳🇱 Tilburg, Noord Brabant, Netherlands

Bernhoven; 🇳🇱 Uden, Noord Brabant, Netherlands

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Overijssel, Netherlands

Deventer Ziekenhuis; 🇳🇱 Deventer, Overijssel, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Overijssel, Netherlands

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Rijnstate; 🇳🇱 Arnhem, Netherlands

HAGA ziekenhuis; 🇳🇱 Den Haag, Netherlands

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

Elisabeth Tweesteden Ziekenhuis; 🇳🇱 Tilburg, Netherlands

Elkerliek; 🇳🇱 Helmond, Noord Brabant, Netherlands

Spaarne Gasthuis; 🇳🇱 Hoofddorp, Noord-Holland, Netherlands

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Zuid Holland, Netherlands

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Zuid-Holland, Netherlands

Ziekenhuis Gelderse Vallei; 🇳🇱 Ede, Netherlands

Ziekenhuis St Antonius; 🇳🇱 Nieuwegein, Netherlands

Viecuri Medisch Centrum; 🇳🇱 Venlo, Limburg, Netherlands

Netherlands Cancer Instituut; 🇳🇱 Amsterdam, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Friesland, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 's-Hertogenbosch, Netherlands

Zuyderland Medisch Centrum; 🇳🇱 Sittard-Geleen, Limburg, Netherlands