A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer

NCT05567835 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: H-50068
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Keywords

Gastric cancer; GEJ cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Pathologic Response Rate

  at week 12 for Arm A and at week 20 for Arm B

• Rate of Pathologic Nodal Stage (ypN1-ypN3)

  at week 12 for Arm A and at week 20 for Arm B

Study Arms (2)

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.

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.

Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Docetaxel; Biological: GSCF

Interventions

Fluorouracil DRUG

2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15

Also known as: 5-FU

Arm A: FLOT-TNT ( Investigational Arm); Arm B: FLOT-POP ( Standard Arm)

Leucovorin DRUG

200 mg mg/m2 IV over 2 hours Day 1,15

Also known as: LV

Arm A: FLOT-TNT ( Investigational Arm); Arm B: FLOT-POP ( Standard Arm)

Oxaliplatin DRUG

85 mg/m2 IV over 2 hours Day 1,15

Also known as: Eloxatin

Arm A: FLOT-TNT ( Investigational Arm); Arm B: FLOT-POP ( Standard Arm)

Docetaxel DRUG

60 mg/m2 IV over 60 minutes Day 1,15

Also known as: Taxotere

Arm A: FLOT-TNT ( Investigational Arm); Arm B: FLOT-POP ( Standard Arm)

GSCF BIOLOGICAL

Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16

Arm A: FLOT-TNT ( Investigational Arm); Arm B: FLOT-POP ( Standard Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (5)

Baylor College of Medicine Medical Center - McNair Campus

Houston, Texas, 77030, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Ben Taub Hospital

Houston, Texas, 77030, United States

Location

Harris Health System- Smith Clinic

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Tannaz Armaghany, MD
• Organization: Baylor College of Medicine

tannaz.armaghany@bcm.edu

832-957-6500

Study Officials

• Tannaz Armaghany, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 5, 2022
• Study Start: March 6, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: April 9, 2026
• Results First Posted: February 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)