Overview
Sponsor-declared trial summary
Gastric Carcinoma
To evaluate the effectiveness of perioperative FLOT4 chemotherapy in combination with preoperative intraperitoneal chemotherapy for hyperthermia (HIPEC) in patients with advanced gastric cancer at high risk of metastases to the peritoneal cavity - the main aim of the study is to reduce the frequency of peritoneal recur…
Key facts
- Sponsor
- Uniwersytet Jagiellonski Collegium Medicum
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Sep 2021 → 28 Jan 2025
- Decision date (initial)
- 2024-09-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516042-18-00
- EudraCT number
- 2020-001419-25
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To evaluate the effectiveness of perioperative FLOT4 chemotherapy in combination with preoperative intraperitoneal chemotherapy for hyperthermia (HIPEC) in patients with advanced gastric cancer at high risk of metastases to the peritoneal cavity - the main aim of the study is to reduce the frequency of peritoneal recurrences 6 months after gastrectomy compared to the group of patients treated without HIPEC.
Secondary objectives 4
- Improvement in overall survival over the period of 6 months, 1 year, 3 and 5 years - counted from the date of gastric resection
- Improvement in disease-free survival over the period of 6 months, 1, 3 and 5 years - counted from the day on which the gastric resection was performed
- Reduction in relapse rates over 6 months, 1, 3 and 5 years
- Assessment of the incidence of postoperative complications on the Clavien-Dindo scale
Conditions and MedDRA coding
Gastric Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10007350 | Carcinoma gastric | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- gastric cancer confirmed in histological examination of material taken during gastroscopy and biopsy of the tumour
- advanced gastric cancer (cT3/T4a, cN0-3b)
- no distant metastases on chest, abdominal and pelvic computed tomography (cM0)
- age 18-75
- signed written informed consent
- completion of at least 3 cycles of preoperative FLOT chemotherapy
Exclusion criteria 9
- lack of confirmation of gastric cancer in histologic examination of biopsy material taken during gastroscopy
- age > 75
- Performance status 3 or higher in ECOG/WHO scale
- previous abdominal surgery other than appendectomy or laparoscopic cholecystectomy
- pregnancy or lactation
- lack of written informed consent
- other simultaneous neoplasm
- previous systemic treatment or radiotherapy for other neoplasm
- serious dysfagia requiring surgical treatment before previous chemotherapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Peritoneal recurrence rate
- Recurrence rates
- Quality of life assessment by means of QLQ-C30 and STO22 questionaries
Secondary endpoints 3
- Overall survival
- Disease free survival
- Ocena parametrów jakości życia przy użyciu kwestionariusza QLQC30 oraz STO22
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP139021 · ATC
- Route of administration
- INFUSION
- Max daily dose
- 300 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX19 — IRINOTECAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uniwersytet Jagiellonski Collegium Medicum
- Sponsor organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Address
- Ul. Sw. Anny 12
- City
- Cracow
- Postcode
- 31-008
- Country
- Poland
Scientific contact point
- Organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Contact name
- Biuro ds. Badan Klinicznych
Public contact point
- Organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Contact name
- Biuro ds. Badan Klinicznych
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 182 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2021-09-08 | 2021-09-08 | 2025-01-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2024-516042-18-00 Final summary of results SUM-108369
|
2025-11-27T08:56:35 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2024-516042-18-00 Lay person summary of results | 2025-11-27T08:57:19 | Submitted | Laypersons Summary of Results |
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 2024-516042-18-00 Lay person summary of results | 1 |
| Protocol (for publication) | D_Approved protocol 2024-516042-18-00_BLINDED | 1.4 |
| Protocol (for publication) | D_Patient facing documents QLQ-C30 | 1 |
| Protocol (for publication) | D_Patient facing documents QLQ-STO22 | 1 |
| Protocol (for publication) | D_Protocol 2024-516042-18-00 | 1.4 |
| Recruitment arrangements (for publication) | Sponsor Statement | 1 |
| Subject information and informed consent form (for publication) | L_SIS and ICF | 1.4 |
| Subject information and informed consent form (for publication) | L_SIS and ICF clause | 1.3 |
| Subject information and informed consent form (for publication) | L_SIS and ICF Leaflet | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Irinotecan Accord | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Campto | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Irinotecan Kabi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Irinotecan Medac | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IRINOTECAN STADA | 1 |
| Summary of results (for publication) | 2024-516042-18-00 Final summary of results | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | Poland | Acceptable 2024-09-02
|
2024-09-06 |