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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.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorouracil | Drug | 2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at week 16 for Arm A and at week 24 for Arm B |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at week 12 for Arm A and at week 20 for Arm B |
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Inclusion Criteria:
i. 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.
l. 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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tannaz Armaghany, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine Medical Center - McNair Campus | Houston | Texas | 77030 | United States | ||
| Baylor College of Medicine |
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Since activation, 3 subjects were enrolled but were not able to be randomized to a treatment arm because of a positive diagnostic laparoscopy result. Given the lack of accrual the study was closed
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: FLOT-TNT ( Investigational Arm) | 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. Fluorouracil: 2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15 Leucovorin: 200 mg mg/m2 IV over 2 hours Day 1,15 Oxaliplatin: 85 mg/m2 IV over 2 hours Day 1,15 Docetaxel: 60 mg/m2 IV over 60 minutes Day 1,15 GSCF: Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2024 |
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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.
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|
| Leucovorin | Drug | 200 mg mg/m2 IV over 2 hours Day 1,15 |
|
|
| Oxaliplatin | Drug | 85 mg/m2 IV over 2 hours Day 1,15 |
|
|
| Docetaxel | Drug | 60 mg/m2 IV over 60 minutes Day 1,15 |
|
|
| GSCF | Biological | Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16 |
|
| 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. |
| at week 12 for Arm A and at week 20 for Arm B |
| Houston |
| Texas |
| 77030 |
| United States |
| Baylor St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| Ben Taub Hospital | Houston | Texas | 77030 | United States |
| Harris Health System- Smith Clinic | Houston | Texas | 77030 | United States |
| FG001 | Arm B: FLOT-POP ( Standard Arm) | 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. Fluorouracil: 2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15 Leucovorin: 200 mg mg/m2 IV over 2 hours Day 1,15 Oxaliplatin: 85 mg/m2 IV over 2 hours Day 1,15 Docetaxel: 60 mg/m2 IV over 60 minutes Day 1,15 GSCF: Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16 |
| COMPLETED |
|
| NOT COMPLETED |
|
Since activation, 3 subjects were enrolled but were ineligible for randomization to a treatment arm. We could not report data in the table because all subjects that signed consent (and were thus considered enrolled per the federal definition of research participant) did not meet protocol inclusion criteria and therefore did not have data collected about them for research purposes past the point of signing the informed consent document.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: FLOT-TNT ( Investigational Arm) | 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. Fluorouracil: 2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15 Leucovorin: 200 mg mg/m2 IV over 2 hours Day 1,15 Oxaliplatin: 85 mg/m2 IV over 2 hours Day 1,15 Docetaxel: 60 mg/m2 IV over 60 minutes Day 1,15 GSCF: Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16 |
| BG001 | Arm B: FLOT-POP ( Standard Arm) | 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. Fluorouracil: 2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15 Leucovorin: 200 mg mg/m2 IV over 2 hours Day 1,15 Oxaliplatin: 85 mg/m2 IV over 2 hours Day 1,15 Docetaxel: 60 mg/m2 IV over 60 minutes Day 1,15 GSCF: Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | |||||||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||||
| Race (NIH/OMB) | 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 randomize an eligible subject; accrual was halted. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We could not report data in the table because all subjects that signed consent (and were thus considered enrolled per the federal definition of research participant) did not meet protocol inclusion criteria and data were not collected because all enrolled participants did not start the study. | Posted | at week 16 for Arm A and at week 24 for Arm B |
|
| ||||||||||||||||||||||
| Secondary | 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). | We could not report data in the table because all subjects that signed consent (and were thus considered enrolled per the federal definition of research participant) did not meet protocol inclusion criteria and data were not collected because all enrolled participants did not start the study. | Posted | at week 12 for Arm A and at week 20 for Arm B |
| |||||||||||||||||||||||
| Secondary | 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. | We could not report data in the table because all subjects that signed consent (and were thus considered enrolled per the federal definition of research participant) did not meet protocol inclusion criteria and data were not collected because all enrolled participants did not start the study. | Posted | at week 12 for Arm A and at week 20 for Arm B |
|
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 randomize an eligible subject; accrual was halted.
No adverse event data were collected because the enrolled participants never started the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: FLOT-TNT ( Investigational Arm) | 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. Fluorouracil: 2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15 Leucovorin: 200 mg mg/m2 IV over 2 hours Day 1,15 Oxaliplatin: 85 mg/m2 IV over 2 hours Day 1,15 Docetaxel: 60 mg/m2 IV over 60 minutes Day 1,15 GSCF: Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Arm B: FLOT-POP ( Standard Arm) | 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. Fluorouracil: 2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15 Leucovorin: 200 mg mg/m2 IV over 2 hours Day 1,15 Oxaliplatin: 85 mg/m2 IV over 2 hours Day 1,15 Docetaxel: 60 mg/m2 IV over 60 minutes Day 1,15 GSCF: Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16 | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tannaz Armaghany, MD | Baylor College of Medicine | 832-957-6500 | tannaz.armaghany@bcm.edu |
| Oct 27, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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|
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