Gastric CancerPhase 3CHIMERANCT04597294
Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
A Phase 3 study testing FLOT + HIPEC + Surgery and FLOT + Surgery in people with Gastric Cancer, run by Jagiellonian University at 1 site in Poland.
Trial summary
The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- FLOT + HIPEC + Surgery and FLOT + Surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2021to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric cancer confirmed histopathologically in tumor specimens.
- Age 18-75 years.
- Advanced gastric cancer cT3 / cT4a / N0-3b.
- No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0).
- Written consent to participate in the study.
Who cannot join
- No clear histopathological confirmation of gastric cancer.
- Age > 75 years.
- Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale).
- Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic).
- Pregnancy and lactation.
- Refusal to participate or an inability to provide written consent.
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- Coexisting cancer in another location.
- Systemic treatment or radiotherapy for another cancer.
- Dysphagia requiring surgical treatment (gastric resection or nutritional jejunostomy) before starting neoadjuvant treatment and indication for accelerated surgery for other reasons.
- Disqualification for perioperative FLOT4 chemotherapy as decided by a multi-specialist consultation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of General, Oncological, Gastroenterological Surgery and Transplantology
Krakow, Lesser Poland Voivodship, 30-688
Piotr Richter, Professor, +48124002400, piotr.richter@uj.edu.pl
About this study
Official title: A Randomized, Multicenter Clinical Trial Comparing the Combination of Perioperative FLOT Chemotherapy and Preoperative Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Plus Gastrectomy to Perioperative FLOT Chemotherapy and Gastrectomy Alone in Patients With Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.
Read the detailed description
This is a randomized, multicenter, clinical trial in which 598 patients with advanced gastric cancer at high risk of peritoneal metastases are randomly allocated to receive either preoperative hyperthermic intraperitoneal chemotherapy (HIPEC) plus gastrectomy (experimental group) or gastrectomy alone (control group). All patients, regardless of allocation, will additionally receive 4 cycles of FLOT chemotherapy (docetaxel 50 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 and 5-fluorouracil 2600 mg/m2) before surgery ± HIPEC and 4 cycles of FLOT chemotherapy after gastrectomy. The main outcome is frequency of peritoneal recurrence by 6-months post-operative. Patients will be followed for 5 years and undergo additional evaluations at 6 months, 1 year, 3 and 5 years.
The study will take place at 7 hospitals across Poland. All participating centers have the equipment and skills to perform all necessary procedures in this study. The below centers specialize in the treatment of stomach cancer with many documented years of experience. They are trained in the maintenance of a register, possess the skills to conduct appropriate research analyses and are equipped with a system for assessing the quality of both surgical and oncological treatment.
- Conditions
- Gastric Cancer
- Being tested
- FLOT + HIPEC + Surgery, FLOT + Surgery
- Keywords
- HIPEC, FLOT, Gastric cancer, Lymphadenectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOT + HIPEC + SurgeryCombination product
Also called Prophylactic HIPEC
HIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy
FLOT + SurgeryCombination product
Also called Perioperative FLOT + Surgery
Perioperative FLOT chemotherapy (4 doses before and 4 doses after gastrectomy) and surgery
| Study group | Role | What they receive |
|---|---|---|
| Perioperative FLOT + prophylactic HIPEC + surgery | Experimental | After 4 doses of preoperative FLOT chemotherapy diagnostic laparoscopy will be performed - patients without distant metastases will be randomised, in those randomised to experimental arm HIPEC with irinotecan will be performed (a dose of 300 mg/m2 body surface area will be administered over 45 minutes at a temperature of 42 degrees Celsius) Receives: Combination Product: FLOT + HIPEC + Surgery |
| Perioperative FLOT + surgery | Active comparator | Standard treatment regimen for advanced gastric cancer Receives: Combination Product: FLOT + Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal recurrence rate
The rate of peritoneal recurrences at 6 month time from randomisation
Measured: 6 months
Secondary outcomes (10)
Overall survival
Overall survival at 6 month follow-up
Measured: 6 months
Overall survival
Overall survival at 3 year follow-up
Measured: 3 years
Overall survival
Overall survival at 5 year follow-up
Measured: 5 years
Local recurrence rate
Locoregional recurrence rate at 3 year follow-up
Measured: 3 years
Systemic recurrence rate
Systemic recurrence rate at 3 year follow-up
Measured: 3 years
Local recurrence rate
Locoregional recurrence rate at 5 year follow-up
Measured: 5 years
Systemic recurrence rate
Systemic recurrence rate at 5 year follow-up
Measured: 5 years
Complications rate
According to CTCAE version 5 and Clavien-Dindo classification
Measured: 6 months
Treatment-related quality of life assessed by Quality Of Life Questionnaire (QLQ) C30 version 3.0
Score range 0-100, higher score represents a higher (better) level of functioning
Measured: 6 months
Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (STO22)
Score range 0-100, higher scores represent worse quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Aug 2021
- Primary completionJan 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 1:1
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radoslaw Pach, MD, PhD, Jagiellonian University
- Investigators
- Piotr Richter, Professor, Study director, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597294
- Sponsor's protocol ID
- Gastric CHIMERA Trial
- Other IDs
- 2020-001419-25, 2019/ABM/01/00020-00
- Acronym
- CHIMERA
- Status last verified
- Mar 2024
- First submitted
- 15 Oct 2020
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Clinical Trial Comparing the Combination of Perioperative FLOT Chemotherapy and Preoperative Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Plus Gastrectomy to Perioperative FLOT Chemotherapy and Gastrectomy Alone in Patients With Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
- ClinicalTrials.gov ID
- NCT04597294
- Acronym / sponsor ID
- CHIMERA / Gastric CHIMERA Trial
- Conditions
- Gastric Cancer
- Keywords
- HIPEC, FLOT, Gastric cancer, Lymphadenectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.
Detailed description
This is a randomized, multicenter, clinical trial in which 598 patients with advanced gastric cancer at high risk of peritoneal metastases are randomly allocated to receive either preoperative hyperthermic intraperitoneal chemotherapy (HIPEC) plus gastrectomy (experimental group) or gastrectomy alone (control group). All patients, regardless of allocation, will additionally receive 4 cycles of FLOT chemotherapy (docetaxel 50 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 and 5-fluorouracil 2600 mg/m2) before surgery ± HIPEC and 4 cycles of FLOT chemotherapy after gastrectomy. The main outcome is frequency of peritoneal recurrence by 6-months post-operative. Patients will be followed for 5 years and undergo additional evaluations at 6 months, 1 year, 3 and 5 years.
The study will take place at 7 hospitals across Poland. All participating centers have the equipment and skills to perform all necessary procedures in this study. The below centers specialize in the treatment of stomach cancer with many documented years of experience. They are trained in the maintenance of a register, possess the skills to conduct appropriate research analyses and are equipped with a system for assessing the quality of both surgical and oncological treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization 1:1
| Arm | Type | Receives |
|---|---|---|
| Perioperative FLOT + prophylactic HIPEC + surgery | Experimental | Combination Product: FLOT + HIPEC + SurgeryAfter 4 doses of preoperative FLOT chemotherapy diagnostic laparoscopy will be performed - patients without distant metastases will be randomised, in those randomised to experimental arm HIPEC with irinotecan will be performed (a dose of 300 mg/m2 body surface area will be administered over 45 minutes at a temperature of 42 degrees Celsius) |
| Perioperative FLOT + surgery | Active comparator | Combination Product: FLOT + SurgeryStandard treatment regimen for advanced gastric cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gastric cancer confirmed histopathologically in tumor specimens.
- Age 18-75 years.
- Advanced gastric cancer cT3 / cT4a / N0-3b.
- No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0).
- Written consent to participate in the study.
Key exclusion criteria (10 listed)
- No clear histopathological confirmation of gastric cancer.
- Age > 75 years.
- Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale).
- Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic).
- Pregnancy and lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLOT + HIPEC + SurgeryAlso: Prophylactic HIPECHIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy | Combination product | Perioperative FLOT + prophylactic HIPEC + surgery |
| FLOT + SurgeryAlso: Perioperative FLOT + SurgeryPerioperative FLOT chemotherapy (4 doses before and 4 doses after gastrectomy) and surgery | Combination product | Perioperative FLOT + surgery |
Primary outcome
Peritoneal recurrence rate
Time frame: 6 months
The rate of peritoneal recurrences at 6 month time from randomisation
10 secondary outcomes
Overall survival
Time frame: 6 months
Overall survival
Time frame: 3 years
Overall survival
Time frame: 5 years
Local recurrence rate
Time frame: 3 years
Systemic recurrence rate
Time frame: 3 years
Local recurrence rate
Time frame: 5 years
Systemic recurrence rate
Time frame: 5 years
Complications rate
Time frame: 6 months
Treatment-related quality of life assessed by Quality Of Life Questionnaire (QLQ) C30 version 3.0
Time frame: 6 months
Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (STO22)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piotr Richter, Professor study director
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FLOT + HIPEC + Surgery and FLOT + Surgery in people with Gastric Cancer, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Richter, Professor (+48124002400, piotr.richter@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal recurrence rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.