Gastric AdenocarcinomaPhase 2TOGARNCT05567835
A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer
A Phase 2 study testing Fluorouracil, Leucovorin and Oxaliplatin in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Baylor College of Medicine at 5 sites in United States.
Trial summary
This is a randomized pilot study to evaluate and to compare the completion rates of Total Neoadjuvant chemotherapy with FLOT ( FLOT-TNT) and perioperative chemotherapy with FLOT ( FLOT-POP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Fluorouracil, Leucovorin and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Mar 2024to 20 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must provide written informed consent.
- Must be ≥18 years of age.
- Must have life expectancy of greater than 3 months.
- Must have pathologically proven Siewert type II or III GEJ or gastric adenocarcinoma from the main tumor or local lymph nodes (pre-neoadjuvant chemo).
- Stage cT2 or higher, any N and M0, are eligible for the study.
- M0 disease must be established by both negative distant metastatic disease on imaging AND negative diagnostic laparoscopic assisted cytology of peritoneal fluid cytology not more than 42 days before registration.
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- Must be a candidate for neoadjuvant chemotherapy.
- Must be a candidate for curative surgical approach.
- Must have an ECOG performance status 0-2.
- Male or female subjects of childbearing potential must be willing to use contraceptive precautions throughout the trial and for 3 months after discontinuation of study treatment. Female subjects of childbearing potential must have a negative pregnancy test within 28 days of registration. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
- Must have adequate kidney, liver, and bone marrow function, within 28 days prior to registration, as follows:
- Hemoglobin ≥ 8.0 gm/dL (PRBC transfusion is allowed to meet this criteria) ii. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 iii. Platelet count ≥ 100,000 /mm3 iv. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) v. AST (SGOT) and ALT (SGPT) ≤ 3.0 times the ULN vi. Patient must have adequate renal function as evidenced by one of the following: Serum creatinine ≤ IULN OR calculated creatinine clearance ≥ 60 mL/min. This serum creatinine result must be obtained within 28 days prior to registration.
- Subjects who have required a short course urgent single modality non curative radiation treatment or gastric artery embolization for the purpose of tumor bleeding control are eligible.
Who cannot join
- Positive cytology or histology for metastatic disease on diagnostic laparoscopy peritoneal fluid. Reports such as: "cannot rule out malignancy" or "suspicious for malignancy, but not definitive" will exclude the subject from enrolling.
- Seiwert type I GEJ cancer
- Subjects with clinical evidence of metastatic disease.
- Biopsy proven metastatic disease (excluding regional lymph nodes)
- Prior chemotherapy for gastric cancer or GEJ cancer
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, current non-advanced prostate cancer per the discretion of the investigator, and any other cancers from which the patient has been disease free for two years.
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- Female subjects who are pregnant, breast feeding, or of childbearing potential with a positive pregnancy test prior to baseline. Women of childbearing potential must have a negative serum pregnancy test as a part of eligibility within 28 days of registration. A persistent positive or elevated urine or blood Beta HCG test may be contributed to the primary diagnosis of GC or GEJ cancer after ruling out ectopic and intrauterine pregnancy and germ cell tumors.
- Subjects unwilling or unable to comply with the protocol or provide written informed consent.
- Any medical condition that, in the opinion of the investigator, would exclude the subject from participating in this study and treatment plan.
- ECOG > 2
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Baylor College of Medicine Medical Center - McNair Campus
Houston, Texas, 77030
Baylor College of Medicine
Houston, Texas, 77030
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Ben Taub Hospital
Houston, Texas, 77030
Harris Health System- Smith Clinic
Houston, Texas, 77030
About this study
Official title: A Randomized, Open Labeled Phase II Pilot Study of Total Neoadjuvant Chemotherapy With FLOT ( FLOT-TNT) VS Standard Perioperative FLOT ( FLOTPOP) in Patients With Gastric or GEJ Cancer, and Assessment of CTDNA as Correlative Biological Response
This is a randomized pilot study to evaluate and to compare the completion rates of Total Neoadjuvant chemotherapy with FLOT ( FLOT-TNT) and perioperative chemotherapy with FLOT ( FLOT-POP).
Read the detailed description
Participants will be randomized 1:1 to either total Neoadjuvant chemotherapy with with FLOT-TNT ( all 4 cycles of chemotherapy before surgery) or standard of care FLOT-POP ( 2 cycles of chemotherapy before surgery and 2 cycles of chemotherapy after surgery). Each cycle of chemo is 28 days long with chemo administered on Days 1 and Day 15 of the cycle.
- Being tested
- Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel, GSCF
- Keywords
- Gastric cancer, GEJ 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.
FluorouracilDrug
Also called 5-FU
2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15
LeucovorinDrug
Also called LV
200 mg mg/m2 IV over 2 hours Day 1,15
OxaliplatinDrug
Also called Eloxatin
85 mg/m2 IV over 2 hours Day 1,15
DocetaxelDrug
Also called Taxotere
60 mg/m2 IV over 60 minutes Day 1,15
GSCFBiological
Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16
| Study group | Role | What they receive |
|---|---|---|
| Arm A: FLOT-TNT ( Investigational Arm) | Experimental | Arm A is the investigational arm with all 4 cycles of FLOT given as total neoadjuvant chemotherapy prior to surgery. Each cycle is 28 days and consists of 2 chemotherapy sessions given every 14 days. The total number of chemotherapy sessions in Arm A is 8. Every effort will be made to have surgery in week 20 ( -1 to +2 weeks), 4 weeks post C4 on arm A. Receives: Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Docetaxel; Biological: GSCF |
| Arm B: FLOT-POP ( Standard Arm) | Experimental | Arm B us the standard perioperative arm with 2 cycles of pre-operative FLOT ( 4 treatment sessions) and 2 cycles ( 4 treatment sessions) of post-operative FLOT. Post-surgery FLOT will start 4-6 weeks post surgery. Each cycle of chemotherapy consists of 28 days and consists of 2 chemotherapy sessions given every 14 days. The total number of chemotherapy sessions in arm B is 8. Every effort should be done to have surgery done in week 12 ( -1 to +2 weeks) post completion of cycle 2 on ARM B. Receives: Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Docetaxel; Biological: GSCF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate of Participants Who Have Completed Their All-allocated Treatments, Either Arm A: FLOT-TNT or Arm B: FLOT-POP
ArmA has all 4 cycles of FLOT given prior to surgery and ArmB has 2 cycles of pre-operative FLOT and 2 cycles of post-operative FLOT. Each cycle consists of 28 days and consists of 2 chemotherapy sessions given every 14 days. The completion rate of participants is presented based on the number of participants who have completed all treatments by their arms.
Measured: at week 16 for Arm A and at week 24 for Arm B
Secondary outcomes (2)
Pathologic Response Rate
The pathological response will be evaluated by using Mandard tumor regression grade (TRG) in the primary tumor. Mandard TRG score is from TRG0 (complete response), TRG1 (near-complete response), TRG2 (partial response), and TRG3 (poor or no response).
Measured: at week 12 for Arm A and at week 20 for Arm B
Rate of Pathologic Nodal Stage (ypN1-ypN3)
Pathologic nodal stage is assessed post gastrectomy surgery and an ordinal variable.
Nodal status is assessed as positive or negative on pathology. The number of positive lymph nodes is obtained from post gastrectomy surgical specimens.
Measured: at week 12 for Arm A and at week 20 for Arm B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start6 Mar 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Why it stopped: Since activation, 3 subjects were enrolled but were ineligible for randomization to a treatment arm because of a positive diagnostic laparoscopy result. Given the repeat inability to enroll and randomize an eligible subject; accrual was halted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Model description
- This study is a two arm phase II pilot design, with eligible subjects randomized 1:1 to either Arm A ( Investigational arm) or Arm B ( Standard arm). The chemotherapy dose modification will follow routine clinical care. Both arms will receive chemotherapy and curative surgery.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tannaz Armaghnay, Baylor College of Medicine
- Investigators
- Tannaz Armaghany, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567835
- Sponsor's protocol ID
- H-50068
- Acronym
- TOGAR
- Status last verified
- Mar 2026
- First submitted
- 1 Oct 2022
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Labeled Phase II Pilot Study of Total Neoadjuvant Chemotherapy With FLOT ( FLOT-TNT) VS Standard Perioperative FLOT ( FLOTPOP) in Patients With Gastric or GEJ Cancer, and Assessment of CTDNA as Correlative Biological Response
- ClinicalTrials.gov ID
- NCT05567835
- Acronym / sponsor ID
- TOGAR / H-50068
- Keywords
- Gastric cancer, GEJ cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Since activation, 3 subjects were enrolled but were ineligible for randomization to a treatment arm because of a positive diagnostic laparoscopy result. Given the repeat inability to enroll and randomize an eligible subject; accrual was halted.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Posted 23 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized pilot study to evaluate and to compare the completion rates of Total Neoadjuvant chemotherapy with FLOT ( FLOT-TNT) and perioperative chemotherapy with FLOT ( FLOT-POP).
Detailed description
Participants will be randomized 1:1 to either total Neoadjuvant chemotherapy with with FLOT-TNT ( all 4 cycles of chemotherapy before surgery) or standard of care FLOT-POP ( 2 cycles of chemotherapy before surgery and 2 cycles of chemotherapy after surgery). Each cycle of chemo is 28 days long with chemo administered on Days 1 and Day 15 of the cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a two arm phase II pilot design, with eligible subjects randomized 1:1 to either Arm A ( Investigational arm) or Arm B ( Standard arm). The chemotherapy dose modification will follow routine clinical care. Both arms will receive chemotherapy and curative surgery.
| Arm | Type | Receives |
|---|---|---|
| Arm A: FLOT-TNT ( Investigational Arm) | Experimental | Drug: Fluorouracil, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Docetaxel, Biological: GSCFArm A is the investigational arm with all 4 cycles of FLOT given as total neoadjuvant chemotherapy prior to surgery. Each cycle is 28 days and consists of 2 chemotherapy sessions given every 14 days. The total number of chemotherapy sessions in Arm A is 8. Every effort will be made to have surgery in week 20 ( -1 to +2 weeks), 4 weeks post C4 on arm A. |
| Arm B: FLOT-POP ( Standard Arm) | Experimental | Drug: Fluorouracil, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Docetaxel, Biological: GSCFArm B us the standard perioperative arm with 2 cycles of pre-operative FLOT ( 4 treatment sessions) and 2 cycles ( 4 treatment sessions) of post-operative FLOT. Post-surgery FLOT will start 4-6 weeks post surgery. Each cycle of chemotherapy consists of 28 days and consists of 2 chemotherapy sessions given every 14 days. The total number of chemotherapy sessions in arm B is 8. Every effort should be done to have surgery done in week 12 ( -1 to +2 weeks) post completion of cycle 2 on ARM B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Must provide written informed consent.
- Must be ≥18 years of age.
- Must have life expectancy of greater than 3 months.
- Must have pathologically proven Siewert type II or III GEJ or gastric adenocarcinoma from the main tumor or local lymph nodes (pre-neoadjuvant chemo).
- Stage cT2 or higher, any N and M0, are eligible for the study.
Key exclusion criteria (10 listed)
- Positive cytology or histology for metastatic disease on diagnostic laparoscopy peritoneal fluid. Reports such as: "cannot rule out malignancy" or "suspicious for malignancy, but not definitive" will exclude the subject from enrolling.
- Seiwert type I GEJ cancer
- Subjects with clinical evidence of metastatic disease.
- Biopsy proven metastatic disease (excluding regional lymph nodes)
- Prior chemotherapy for gastric cancer or GEJ cancer
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 |
|---|---|---|
| FluorouracilAlso: 5-FU2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15 | Drug | Arm A: FLOT-TNT ( Investigational Arm), Arm B: FLOT-POP ( Standard Arm) |
| LeucovorinAlso: LV200 mg mg/m2 IV over 2 hours Day 1,15 | Drug | Arm A: FLOT-TNT ( Investigational Arm), Arm B: FLOT-POP ( Standard Arm) |
| OxaliplatinAlso: Eloxatin85 mg/m2 IV over 2 hours Day 1,15 | Drug | Arm A: FLOT-TNT ( Investigational Arm), Arm B: FLOT-POP ( Standard Arm) |
| DocetaxelAlso: Taxotere60 mg/m2 IV over 60 minutes Day 1,15 | Drug | Arm A: FLOT-TNT ( Investigational Arm), Arm B: FLOT-POP ( Standard Arm) |
| GSCFRecommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16 | Biological | Arm A: FLOT-TNT ( Investigational Arm), Arm B: FLOT-POP ( Standard Arm) |
Primary outcome
Completion Rate of Participants Who Have Completed Their All-allocated Treatments, Either Arm A: FLOT-TNT or Arm B: FLOT-POP
Time frame: at week 16 for Arm A and at week 24 for Arm B
ArmA has all 4 cycles of FLOT given prior to surgery and ArmB has 2 cycles of pre-operative FLOT and 2 cycles of post-operative FLOT. Each cycle consists of 28 days and consists of 2 chemotherapy sessions given every 14 days. The completion rate of participants is presented based on the number of participants who have completed all treatments by their arms.
2 secondary outcomes
Pathologic Response Rate
Time frame: at week 12 for Arm A and at week 20 for Arm B
Rate of Pathologic Nodal Stage (ypN1-ypN3)
Time frame: at week 12 for Arm A and at week 20 for Arm B
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Tannaz Armaghany, MD principal investigator
Baylor College of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorouracil, Leucovorin and Oxaliplatin in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Baylor College of Medicine at 5 sites in United States.
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 13 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: stopped early, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Completion Rate of Participants Who Have Completed Their All-allocated Treatments, Either Arm A: FLOT-TNT or Arm B: FLOT-POP (time frame: at week 16 for Arm A and at week 24 for Arm B). 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 9 Apr 2026.