Critics-Ii

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Oct 2017 → ongoing

Decision date (initial)

2024-06-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-503248-15-00

EudraCT number

2015-004627-31

ClinicalTrials.gov

NCT02931890

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectablegastric cancer

Secondary objectives 10

1. To assess time to event of all treatment arms
2. To assess which preoperative regimen provides superior time-to-recurrence (TTR)
3. To assess which preoperative regimen is most feasible, based on toxicity, pCR and R0 resection rates
4. To assess the toxicity profile of all treatment arms
5. To document surgical morbidity, including incidence of anastomotic leakage
6. To determine the pCR rates of all treatment arms
7. To determine the R0 resection rates of all treatment arms
8. To determine the response rate (RR) of all treatment arms
9. To determine the OS of all treatment arms
10. To identify which preoperative regimen (CRITICS-II) will be compared with the new standard treatment (CRITICS-I) in a nextphase III trial

Conditions and MedDRA coding

Patients with TNM 8th ed stage IB-IIC gastric adenocacinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. TNM 8th ed IB- IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involvegastro-oesophageal junction
2. WHO < 2
3. Age ≥ 18 yrs
4. Resectable adenocarcinoma of the stomach or gastro-oesophageal junction
5. No prior abdominal radiotherapy
6. Haematology: Hb ≥ 5.0 mmol/l; leukocytes ≥ 3.0x109/l, neutrophils ≥ 1.5x109/l, thrombocytes ≥ 100x109/l
7. Renal function: serum creatinine ≤ 1.25x ULN, creatinine clearance ≥ 50 ml/min (calculated by Cockcroft and Gault formula)
8. Liver function: total bilirubin ≤ 1.5x ULN, alkaline phosphatase and ASAT/ALAT ≤ 3x ULN
9. At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesions and/or substantial freeperitoneal fluid if any should be pathologically proven tumor negative
10. Start treatment within 15 working days after randomisation
11. Written informed consent
12. Expected adequacy of follow-up
13. 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 15

1. T1N0 disease endoscopic ultrasound
2. Distant metastases
3. Irresectable patients; due to technical surgery-related factors or general condition
4. 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 afterconsultation of the principal investigator
5. Solitary functioning kidney that will be within the radiation field
6. Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of majorsurgery
7. Uncontrolled (bacterial) infections
8. Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
9. Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias
10. Continuous use of immunosuppressive agents equivalent to >10 mg daily prednison
11. Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
12. Neurotoxicity > CTC grade 1
13. Pregnancy or breast feeding
14. Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
15. Gastric or gastro-esophageal stent within radiation field

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Event‐free survival at 1 year after randomisation (events: local recurrence, regional recurrence, local‐regional recurrence or progression, distant recurrence, or death from any cause).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis

Sponsor organisation

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis

Address

Plesmanlaan 121

City

Amsterdam

Postcode

1066 CX

Country

Netherlands

Scientific contact point

Organisation

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis

Contact name

Marcel Verheij

Public contact point

Organisation

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis

Contact name

Marcel Verheij

Locations

1 EU/EEA country · 28 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications