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Multicentric Randomised Trial for Resectable Gastric Cancer (CRITICS-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02931890
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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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

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Docetaxel Drug: Oxaliplatin Drug: Capecitabine Procedure: gastrectomy Radiation: radiotherapy of gastric cancer Drug: Paclitaxel Drug: Carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: neo-adjuvant chemotherapy followed by surgery
4 courses of 3 weekly DOC followed by surgery
 Drug: Docetaxel
3 weekly course of docetaxel i.v in arm 1 and 2
Other Name: Taxotere

Drug: Oxaliplatin
3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2
Other Name: Eloxatin

Drug: Capecitabine
oral capecitabine in arm 1 and 2
Other Name: Xeloda

Procedure: gastrectomy
resection of gastric cancer after pre-operative chemotherapy for all arms
Active Comparator: neo-adjuvant chemo and subsequent CRT followed by surgery
2 courses of 3 weekly DOC and subsequent CRT followed by surgery
 Drug: Docetaxel
3 weekly course of docetaxel i.v in arm 1 and 2
Other Name: Taxotere

Drug: Oxaliplatin
3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2
Other Name: Eloxatin

Drug: Capecitabine
oral capecitabine in arm 1 and 2
Other Name: Xeloda

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)

Drug: Carboplatin
5 weeks of carboplatin i.v once a week (in arm 2 and 3)
Active Comparator: neo-adjuvant chemoradiotherapy followed by surgery
chemoradiotherapy followed by surgery
 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)

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


Outcome Measures
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Primary Outcome Measures :
  1. Event-Free survival [ Time Frame: 1 year ]
    Event-free survival will be measured by clinical outcome and CT-scan


Secondary Outcome Measures :
  1. Time to Event (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence, or death from any cause) [ Time Frame: 1 year ]
    Interval between randomization and event measured by clinical outcome and CT scan

  2. Time to recurrence (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence) [ Time Frame: 1 year ]
    Interval between randomization and recurrence determined by clinical outcome and CT scan

  3. Toxicity [ Time Frame: 1 year ]
    Number of patients with treatment-related adverse events as assessed by CTCAE v4.0


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931890


Contacts
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Contact: Marcel Verheij, MD, PhD +31 20 512 9111 m.verheij@nki.nl
Contact: Romy van Amelsfoort, MD +31 20 512 9111 epm.jansen@nki.nl

Locations
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Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Marcel Verheij, MD, PhD The Netherlands Cancer Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02931890    
Other Study ID Numbers: M15CRI
NL 55436.031.015 ( Registry Identifier: CCMO )
2015-004627-31 ( EudraCT Number )
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
gastric cancer
radiotherapy
chemoradiotherapy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Docetaxel
Carboplatin
 Capecitabine
Oxaliplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites