Gastric CancerPhase 2PECORINONCT04937738
Perioperative Chemotherapy in Gastric Cancer
A Phase 2 study testing Docetaxel, Oxaliplatin and Leucovorin in people with Gastric Cancer, run by Ukrainian Society of Clinical Oncology at 1 site in Ukraine.
Trial summary
Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Docetaxel, Oxaliplatin and Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUkraine
- Study dates
- 21 Jul 2021to 1 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery)
- cN0-3
- M0
- Age: 18 - 80
- ECOG: 0 - 1
- Histological type: adenocarcinoma
Show all 11Show fewer
- Differentiation grade: G0 - G4
- No previous surgery
- No previous chemotherapy
- No concomitant severe comorbidity
- Written informed consent
Who cannot join
- cT1a, cT4b (invasion in truncus, hepatic artery, proximal part of splenic artery)
- Presense of distant metastases
- ECOG: 2 - 5
- Age: <18 and >80
- Severe concomitant comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Discontinuation Associated With Perioperative Toxicity of FLOT Versus XELOX Chemotherapy in Patient With Resectable Gastric Cancer; Phase 2
Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.
Read the detailed description
328 рatients with resectable (T1b-4 and/or N-/+, M0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After staging laparocopy patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by curative surgery. Adjuvant chemotherapy will be given as 4 cycles of FLOT or 4 cycles XELOX. The primary endpoint is the proportion of patients who fully adhered to all the allocated treatment per protocol. Secondary endpoints are pathological regression grade, progression free survival, overall survival, chemotherapy and surgery complications rates.
- Conditions
- Gastric Cancer
- Being tested
- Docetaxel, Oxaliplatin, Leucovorin, Fluorouracil, Capecitabine
- Keywords
- perioperative chemotherapy, pathological responce rate, gastrectomy, gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
50mg/m2, d1, i.v., every 2 weeks
OxaliplatinDrug
85 mg/m², d1, i.v., every 2 weeks
LeucovorinDrug
200 mg/m², d1, i.v., every 2 weeks
FluorouracilDrug
2600 mg/m²d1 i.v. every 2 weeks
CapecitabineDrug
1000 mg/m² two times per day (BID), d1-14
OxaliplatinDrug
Also called oxaliplatine
130 mg/m² d1 i.v. every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Perioperative XELOX chemotherapy | Active comparator | Oxaliplatin 130 mg/m2, d1 Capecitabine 1000 mg/m² two times per day (BID), d1-14, every 3 weeks (q3w) 4 cycles (12 weeks) pre-OP and 3 cycles (12 weeks) post-OP Receives: Drug: Capecitabine; Drug: Oxaliplatin |
| Perioperative FLOT chemotherapy | Experimental | Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who complete all the treatment per protocol
Completed treatment protocol is considered as 4 cycles neoadjuvant chemotherapy followed by curative surgery and 4 cycles of adjuvant chemotherapy.
Measured: Up to 2 months
Secondary outcomes (6)
Chemotherapy toxicity profile
To determine and compare toxicity profile in patients receiving XELOX or FLOT regimen
Measured: at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days)
Surgical complications rate
To determine surgical complication rate and profile after different types of regimens in neoadjuvant settings
Measured: up to 90th day after surgery
1-year disease-free survival rate
To determine the efficacy of FLOT regimen compared to XELOX regimen during the first year after the surgery
Measured: 1 year after surgery
Correlation between histopathological regression and disease-free survival
To determine correlation between histopathological regression and disease-free survival in different chemotherapeutic settings
Measured: 2 years of follow-up after the last cycle of chemotherapy
Median overall survival
To determine the efficacy of FLOT regimen compared to XELOX regimen by assessment of overall survival
Measured: 5 year follow up after the last cycle of chemotherapy
Histopathological regression rate (Becker regression criteria)
To determine histopathological regression rate after FLOT regimen compared to XELOX regimen in neoadjuvant settings
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start21 Jul 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: High rate of disease progression in XELOX arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Clinical Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oleksii Dobrzhanskiy, National Cancer Institute (NCI)
- Investigators
- Oleksii Dobrzhanskyi, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937738
- Sponsor's protocol ID
- 275
- Acronym
- PECORINO
- Status last verified
- Nov 2024
- First submitted
- 4 Jun 2021
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the initial publication every participant will recieve all the data to provide further data exploration.
Publications
Dobrzhanskyi O, Kopetskyi V, Ross EA, Chernoff J, Shudrak Y, Kolesnyk A, Pepenin M, Horodetskyi A, Melnitchouk N, Kondratskyi Y. Treatment discontinuation associated with perioperative toxicity of FLOT versus XELOX chemotherapy in patients with resectable gastric cancer: prospective randomized trial (PECORINO). J Gastrointest Oncol. 2025 Jun 30;16(3):909-921. doi: 10.21037/jgo-2024-921. Epub 2025 Jun 24.
PubMed 40672074
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Discontinuation Associated With Perioperative Toxicity of FLOT Versus XELOX Chemotherapy in Patient With Resectable Gastric Cancer; Phase 2
- ClinicalTrials.gov ID
- NCT04937738
- Acronym / sponsor ID
- PECORINO / 275
- Conditions
- Gastric Cancer
- Keywords
- perioperative chemotherapy, pathological responce rate, gastrectomy, gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High rate of disease progression in XELOX arm
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ukrainian Society of Clinical OncologyUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 24 Jun 2021 (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.
Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.
Detailed description
328 рatients with resectable (T1b-4 and/or N-/+, M0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After staging laparocopy patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by curative surgery. Adjuvant chemotherapy will be given as 4 cycles of FLOT or 4 cycles XELOX. The primary endpoint is the proportion of patients who fully adhered to all the allocated treatment per protocol. Secondary endpoints are pathological regression grade, progression free survival, overall survival, chemotherapy and surgery complications rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative XELOX chemotherapy | Active comparator | Drug: Capecitabine, Drug: OxaliplatinOxaliplatin 130 mg/m2, d1 Capecitabine 1000 mg/m² two times per day (BID), d1-14, every 3 weeks (q3w) 4 cycles (12 weeks) pre-OP and 3 cycles (12 weeks) post-OP |
| Perioperative FLOT chemotherapy | Experimental | Drug: Docetaxel, Drug: Oxaliplatin, Drug: Leucovorin, Drug: FluorouracilDocetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery)
- cN0-3
- M0
- Age: 18 - 80
- ECOG: 0 - 1
Key exclusion criteria (5 listed)
- cT1a, cT4b (invasion in truncus, hepatic artery, proximal part of splenic artery)
- Presense of distant metastases
- ECOG: 2 - 5
- Age: <18 and >80
- Severe concomitant comorbidity
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 |
|---|---|---|
| Docetaxel50mg/m2, d1, i.v., every 2 weeks | Drug | Perioperative FLOT chemotherapy |
| Oxaliplatin85 mg/m², d1, i.v., every 2 weeks | Drug | Perioperative FLOT chemotherapy |
| Leucovorin200 mg/m², d1, i.v., every 2 weeks | Drug | Perioperative FLOT chemotherapy |
| Fluorouracil2600 mg/m²d1 i.v. every 2 weeks | Drug | Perioperative FLOT chemotherapy |
| Capecitabine1000 mg/m² two times per day (BID), d1-14 | Drug | Perioperative XELOX chemotherapy |
| OxaliplatinAlso: oxaliplatine130 mg/m² d1 i.v. every 3 weeks | Drug | Perioperative XELOX chemotherapy |
Primary outcome
Proportion of patients who complete all the treatment per protocol
Time frame: Up to 2 months
Completed treatment protocol is considered as 4 cycles neoadjuvant chemotherapy followed by curative surgery and 4 cycles of adjuvant chemotherapy.
6 secondary outcomes
Chemotherapy toxicity profile
Time frame: at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days)
Surgical complications rate
Time frame: up to 90th day after surgery
1-year disease-free survival rate
Time frame: 1 year after surgery
Correlation between histopathological regression and disease-free survival
Time frame: 2 years of follow-up after the last cycle of chemotherapy
Median overall survival
Time frame: 5 year follow up after the last cycle of chemotherapy
Histopathological regression rate (Becker regression criteria)
Time frame: 2 weeks after surgery
Results and safety
The study was stopped early (reason given: High rate of disease progression in XELOX arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Derived from this study: PubMed 40672074Dobrzhanskyi O, Kopetskyi V, Ross EA, Chernoff J, Shudrak Y, Kolesnyk A, Pepenin M, Horodetskyi A, Melnitchouk N, Kondratskyi Y. Treatment discontinuation associated with perioperative toxicity of FLOT versus XELOX chemotherapy in patients with resectable gastric cancer: prospective randomized trial (PECORINO). J Gastrointest Oncol. 2025 Jun 30;16(3):909-921. doi: 10.21037/jgo-2024-921. Epub 2025 Jun 24.
- Individual participant dataSharing planned: Yes. After the initial publication every participant will recieve all the data to provide further data exploration.
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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. This study is not recruiting at the moment.
Oleksii Dobrzhanskyi, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Oxaliplatin and Leucovorin in people with Gastric Cancer, run by Ukrainian Society of Clinical Oncology at 1 site in Ukraine.
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 11 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 Nov 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 Ukraine. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: High rate of disease progression in XELOX arm). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who complete all the treatment per protocol (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04937738, which also lists 1 linked publication.
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 Nov 2024.