Multicentric Randomised Trial for Resectable Gastric Cancer

Gastric Cancer Clinical Trial

— CRITICS-II  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02931890
• Other study ID #: M15CRI
• Secondary ID: NL 55436.031.015
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 21, 2017
• Est. completion date: March 2029

Study information

• Verified date: April 2024
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 207
• Est. completion date: March 2029
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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

Procedure:
• gastrectomy
resection of gastric cancer after pre-operative chemotherapy for all arms

Radiation:
• radiotherapy of gastric cancer
5 weeks of radiation, 5 times a week with a total of 45 Gy (in arm 2 and 3)

Drug:
• 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)

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Ziekenhuisgroep Twente	Almelo	Overijssel
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Netherlands Cancer Instituut	Amsterdam
Netherlands	Rijnstate	Arnhem
Netherlands	Reinier de Graaf Gasthuis	Delft	Zuid-Holland
Netherlands	HAGA ziekenhuis	Den Haag
Netherlands	Elkerliek	Deurne	Noord Brabant
Netherlands	Deventer Ziekenhuis	Deventer	Overijssel
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord Brabant
Netherlands	Maxima Medisch Centrum	Eindhoven	Noord Brabant
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel
Netherlands	St. Anna Zorggroep	Geldrop	Noord Brabant
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Elkerliek	Helmond	Noord Brabant
Netherlands	Spaarne Gasthuis	Hoofddorp	Noord-Holland
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesland
Netherlands	Radiotherapeutisch Instituut Friesland	Leeuwarden	Friesland
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid Holland
Netherlands	Ziekenhuis St Antonius	Nieuwegein
Netherlands	Zuyderland Medisch Centrum	Sittard-Geleen	Limburg
Netherlands	Elisabeth Tweesteden Ziekenhuis	Tilburg
Netherlands	Instituut Verbeeten	Tilburg	Noord Brabant
Netherlands	Bernhoven	Uden	Noord Brabant
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Netherlands	Maxima Medisch Centrum	Veldhoven	Noord Brabant
Netherlands	Viecuri Medisch Centrum	Venlo	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-Free survival	Event-free survival will be measured by clinical outcome and CT-scan	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	Toxicity	Number of patients with treatment-related adverse events as assessed by CTCAE v4.0	1 year