Gastric CancerPhase 2/3OCTASURNCT06028737
Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer
A Phase 2/3 study testing Docetaxel, Oxaliplatin and Leucovorin in people with Gastric Cancer and Stomach Cancer, run by Ukrainian Society of Clinical Oncology at 2 sites in 2 countries.
Trial summary
The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Stomach Cancer, GastroEsophageal 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
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Mar 2025to 31 Dec 2032
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor spread according to TNM: ≥cT3 and/or ≥cN0 and M0 (except of invasion of the common hepatic artery, celiac trunk, proximal part of the splenic artery, aorta, head of the pancreas);
- Performance status by Eastern Cooperative Oncology Group (ECOG): 0 - 1;
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert type 2/3) adenocarcinoma.
- Differentiation grade: G0 - G4;
- Tumor localization: cardio-esophageal junction (Siewert 2, 3), cardiac part of the stomach, body of the stomach, antral part of the stomach, pyloric part of the stomach;
- Tumor extension: esophagus, diaphragm, liver, body and tail of the pancreas, anterior abdominal wall, small and large intestine, distal part of the splenic artery, spleen;
- Patient agrees to participate in this biomedical study.
Who cannot join
- Presence of another oncological disease at a different site if less than 5 years have passed since radical treatment.
- Comorbidities or patient conditions that preclude the administration of chemotherapy.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Lithuania1 site, 1 recruiting
- Recruiting
National Cancer Institute
Vilnius, 08406
Augustinas Baušys, MD, PhD, +37062363865, abpelikanas@gmail.com
Ukraine1 site, 1 recruiting
- Recruiting
National Cancer Institute
Kyiv, 03022
Mykyta Pepenin, MD, +380959448858, pepenin95@gmail.com
Andrii Horodetskiy, +380990864410, gorodeckij03@gmail.com
About this study
Official title: Total Neoadjuvant Chemotherapy With 5-fluoruracil, Leucovorin, Oxaliplatin, and Docetaxel in Locally Advanced Gastric and Gastroesophageal Junction Cancer (OCTASUR): Randomized, Multi-center, Open-label Trial, Phase 2/3
The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery:
- 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, and Docetaxel (FLOT) followed by surgery.
- 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.
Read the detailed description
This is a multi-center international European prospective randomized study that aims to enroll participants with resectable locally advanced gastric and gastroesophageal (Siewert 2, 3) adenocarcinoma (≥cT3 and/or ≥cN0 and M0) with no history of previous oncological treatment during the last five years, who will be included in this study after reading and signing the informed consent. After the initial diagnostic laparoscopy, patients will be randomized into two groups in a 1:1 ratio, with allocation to one of the two study groups.
Patients randomized to the first (control) group will receive eight cycles of the perioperative FLOT chemotherapy scheme: 4 cycles before surgical treatment and four cycles after surgical intervention. Patients randomized to the second (study) group will receive eight cycles of FLOT total neoadjuvant chemotherapy, followed by surgery.
The study's primary endpoint is the proportion of patients receiving all planned chemotherapy cycles and radical surgical treatment. Secondary endpoints are perioperative morbidity and mortality (surgical and chemotherapeutic complications); disease-free survival (DFS) and 1-, 3- and 5-years overall survival (OS); quality of life during and after the treatment; correlation between the pathohistological response and chemotherapy regimen; composition and biomarkers of gut microbiota; objective tumor response.
Based on previous studies, with the current standard treatment protocol-four cycles of FLOT chemotherapy before surgery and four cycles after-only 47% of patients complete all eight cycles. In contrast, with total neoadjuvant therapy, where the entire chemotherapy regimen is administered before surgery, 71% of patients are able to complete all eight FLOT cycles.
Given these findings, it was calculated that to ensure 80% study power with a two-sided 5% significance level, each study group should include 65 participants. Considering an expected dropout rate of 15%, a total of 150 patients will be recruited. Up to 40 patients will be enrolled in Vilnius, Lithuania, with the remaining participants recruited in Kyiv, Ukraine.
- Conditions
- Gastric Cancer, Stomach Cancer, GastroEsophageal Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Advanced Gastric Adenocarcinoma
- Being tested
- Docetaxel, Oxaliplatin, Leucovorin, Fluorouracil
- Keywords
- Total neoadjuvant chemotherapy, FLOT, Fluoruracil, Gastrectomy, Perioperative chemotherapy, Docetaxel, Leucovorin, Gastric resection, Gastric cancer
- Medical subject headings
- Stomach Neoplasms, Gastrointestinal Neoplasms, 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
| Study group | Role | What they receive |
|---|---|---|
| Perioperative 4+4 FLOT cycles | Active comparator | 4 cycles of neoadjuvant FLOT chemotherapy regimen, followed by surgery and 4 cycles of adjuvant FLOT chemotherapy regimen. Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil |
| Total Neoadjuvant ChemoTherapy (TNT) 8 FLOT cycles | Experimental | 8 cycles of total neoadjuvant FLOT chemotherapy regimen, followed by surgery. 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.
All 8 planned FLOT cycles tolerance rate.
The proportion of patients receiving all planned cycles of chemotherapy and radical surgical treatment.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (10)
Chemotherapy toxicity rate and profile.
To determine chemotherapeutic toxicity profile, according to Common Terminology Criteria for Adverse Events (CTCEA 5.0).
Measured: At the end of each FLOT cycle (each cycle is 14 days), up to 14 days after the last cycle.
Surgical complications rate.
To determine postoperative surgical complications rate and profile after the different chemotherapy regimens, according to Clavien-Dindo classification.
Measured: 30 days after surgery.
Median overall survival.
To determine the efficacy of TNT FLOT regimen compared to perioperative FLOT regimen by assessment of overall survival.
Measured: From the start of treatment to the patient's death or the end of follow-up - 5 years follow-up after the last intervention.
Progression-free survival.
To determine the efficacy of total neoadjuvant FLOT regimen compared to perioperative FLOT regimen.
Measured: Calculated as the time from the start of treatment to disease progression or the end of follow-up at 5 years after the treatment completion.
Quality of patients' life.
To determine the quality of life during the chemotherapy in both groups, after the surgery and 2 years follow-up after the treatment completion, assessed using a standardized European Organisation for Research and Treatment of Cancer quality-of-life questionnaire Core Questionnaire (EORTC QLQ-C30). Values from 30 to 126 mean a better or worse outcome, respectively.
Measured: 24 months.
Quality of patients' life.
To determine the quality of life during the chemotherapy in both groups, after the surgery and 2 years follow-up after the completion of treatment, assessed using standardized European Organisation for Research and Treatment of Cancer quality-of-life questionnaires for Gastric Cancer (EORTC QLQ-STO22). Values from 22-88 mean a better or worse outcome, respectively.
Measured: 24 months.
Correlation between the pathohistological response and overall and disease-free survival.
To determine the correlation between the pathohistological response and overall and progression-free survival, using the Becker criteria.
Measured: 21 days after surgery.
Histopathological tumor response rate (Becker regression criteria).
To determine the pathohistological regression rate after 8 FLOT cycles in total neoadjuvant regimen compared to 4 FLOT cycles in neoadjuvant regimen.
Measured: 21 days after surgery
Intestinal microbiome composition.
Significant differences in the alpha-diversity of the intestinal microbiome between patients with a good and poor response to neoadjuvant chemotherapy.
Measured: Within 7 days before the start of the treatment.
Objective tumor response.
Assessed according to RECIST v1.1 criteria based on preoperative and control computed tomography.
Measured: From within 7 days before the first chemotherapy course and until 4 weeks before the surgical intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start25 Mar 2025
- Primary completion25 Apr 2027 (estimated)
- Study completion31 Dec 2032 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Clinical Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mykyta Pepenin, Ukrainian Society of Clinical Oncology
- Investigators
- Mykyta Pepenin, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028737
- Sponsor's protocol ID
- 241/4
- Acronym
- OCTASUR
- Status last verified
- Apr 2025
- First submitted
- 26 Aug 2023
- Last updated
- 6 May 2025
- 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 receive all the data to provide further data exploration.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant Chemotherapy With 5-fluoruracil, Leucovorin, Oxaliplatin, and Docetaxel in Locally Advanced Gastric and Gastroesophageal Junction Cancer (OCTASUR): Randomized, Multi-center, Open-label Trial, Phase 2/3
- ClinicalTrials.gov ID
- NCT06028737
- Acronym / sponsor ID
- OCTASUR / 241/4
- Conditions
- Gastric Cancer, Stomach Cancer, GastroEsophageal Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Advanced Gastric Adenocarcinoma
- Keywords
- Total neoadjuvant chemotherapy, FLOT, Fluoruracil, Gastrectomy, Perioperative chemotherapy, Docetaxel, Leucovorin, Gastric resection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ukrainian Society of Clinical OncologyUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 25 Apr 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 8 Sep 2023 (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 main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery:
- 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, and Docetaxel (FLOT) followed by surgery.
- 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.
Detailed description
This is a multi-center international European prospective randomized study that aims to enroll participants with resectable locally advanced gastric and gastroesophageal (Siewert 2, 3) adenocarcinoma (≥cT3 and/or ≥cN0 and M0) with no history of previous oncological treatment during the last five years, who will be included in this study after reading and signing the informed consent. After the initial diagnostic laparoscopy, patients will be randomized into two groups in a 1:1 ratio, with allocation to one of the two study groups.
Patients randomized to the first (control) group will receive eight cycles of the perioperative FLOT chemotherapy scheme: 4 cycles before surgical treatment and four cycles after surgical intervention. Patients randomized to the second (study) group will receive eight cycles of FLOT total neoadjuvant chemotherapy, followed by surgery.
The study's primary endpoint is the proportion of patients receiving all planned chemotherapy cycles and radical surgical treatment. Secondary endpoints are perioperative morbidity and mortality (surgical and chemotherapeutic complications); disease-free survival (DFS) and 1-, 3- and 5-years overall survival (OS); quality of life during and after the treatment; correlation between the pathohistological response and chemotherapy regimen; composition and biomarkers of gut microbiota; objective tumor response.
Based on previous studies, with the current standard treatment protocol-four cycles of FLOT chemotherapy before surgery and four cycles after-only 47% of patients complete all eight cycles. In contrast, with total neoadjuvant therapy, where the entire chemotherapy regimen is administered before surgery, 71% of patients are able to complete all eight FLOT cycles.
Given these findings, it was calculated that to ensure 80% study power with a two-sided 5% significance level, each study group should include 65 participants. Considering an expected dropout rate of 15%, a total of 150 patients will be recruited. Up to 40 patients will be enrolled in Vilnius, Lithuania, with the remaining participants recruited in Kyiv, Ukraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative 4+4 FLOT cycles | Active comparator | Drug: Docetaxel, Drug: Oxaliplatin, Drug: Leucovorin, Drug: Fluorouracil4 cycles of neoadjuvant FLOT chemotherapy regimen, followed by surgery and 4 cycles of adjuvant FLOT chemotherapy regimen. |
| Total Neoadjuvant ChemoTherapy (TNT) 8 FLOT cycles | Experimental | Drug: Docetaxel, Drug: Oxaliplatin, Drug: Leucovorin, Drug: Fluorouracil8 cycles of total neoadjuvant FLOT chemotherapy regimen, followed by surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Tumor spread according to TNM: ≥cT3 and/or ≥cN0 and M0 (except of invasion of the common hepatic artery, celiac trunk, proximal part of the splenic artery, aorta, head of the pancreas);
- Performance status by Eastern Cooperative Oncology Group (ECOG): 0 - 1;
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert type 2/3) adenocarcinoma.
- Differentiation grade: G0 - G4;
- Tumor localization: cardio-esophageal junction (Siewert 2, 3), cardiac part of the stomach, body of the stomach, antral part of the stomach, pyloric part of the stomach;
Key exclusion criteria (2 listed)
- Presence of another oncological disease at a different site if less than 5 years have passed since radical treatment.
- Comorbidities or patient conditions that preclude the administration of chemotherapy.
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 4+4 FLOT cycles, Total Neoadjuvant ChemoTherapy (TNT) 8 FLOT cycles |
| Oxaliplatin85 mg/m², d1, i.v., every 2 weeks | Drug | Perioperative 4+4 FLOT cycles, Total Neoadjuvant ChemoTherapy (TNT) 8 FLOT cycles |
| Leucovorin200 mg/m², d1, i.v., every 2 weeks | Drug | Perioperative 4+4 FLOT cycles, Total Neoadjuvant ChemoTherapy (TNT) 8 FLOT cycles |
| Fluorouracil2600 mg/m²d1 i.v. every 2 weeks | Drug | Perioperative 4+4 FLOT cycles, Total Neoadjuvant ChemoTherapy (TNT) 8 FLOT cycles |
Primary outcome
All 8 planned FLOT cycles tolerance rate.
Time frame: From enrollment to the end of treatment at 12 weeks
The proportion of patients receiving all planned cycles of chemotherapy and radical surgical treatment.
10 secondary outcomes
Chemotherapy toxicity rate and profile.
Time frame: At the end of each FLOT cycle (each cycle is 14 days), up to 14 days after the last cycle.
Surgical complications rate.
Time frame: 30 days after surgery.
Median overall survival.
Time frame: From the start of treatment to the patient's death or the end of follow-up - 5 years follow-up after the last intervention.
Progression-free survival.
Time frame: Calculated as the time from the start of treatment to disease progression or the end of follow-up at 5 years after the treatment completion.
Quality of patients' life.
Time frame: 24 months.
Quality of patients' life.
Time frame: 24 months.
Correlation between the pathohistological response and overall and disease-free survival.
Time frame: 21 days after surgery.
Histopathological tumor response rate (Becker regression criteria).
Time frame: 21 days after surgery
Intestinal microbiome composition.
Time frame: Within 7 days before the start of the treatment.
Objective tumor response.
Time frame: From within 7 days before the first chemotherapy course and until 4 weeks before the surgical intervention.
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 May 2025.
- Individual participant dataSharing planned: Yes. After the initial publication every participant will receive 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.
Mykyta Pepenin, MD principal investigator
National Cancer Institute (NCI)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Docetaxel, Oxaliplatin and Leucovorin in people with Gastric Cancer and Stomach Cancer, run by Ukrainian Society of Clinical Oncology at 2 sites in 2 countries.
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 7 inclusion and 2 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 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania, 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 combined 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.
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 Mykyta Pepenin, MD (+380959448858, pepenin95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All 8 planned FLOT cycles tolerance rate. (time frame: From enrollment to the end of treatment at 12 weeks). 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 May 2025.