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

NCT ID: NCT05567835

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-06
• Study Completion Date: 2025-02-20

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).

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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluorouracil

Intervention Type: DRUG

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

Leucovorin

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Docetaxel

Intervention Type: DRUG

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

GSCF

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Fluorouracil

Intervention Type: DRUG

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

Leucovorin

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Docetaxel

Intervention Type: DRUG

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

GSCF

Intervention Type: BIOLOGICAL

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

Interventions

Fluorouracil

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

Intervention Type: DRUG

Leucovorin

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

Docetaxel

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

Intervention Type: DRUG

GSCF

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

Intervention Type: BIOLOGICAL

Other Intervention Names

5-FU; LV; Eloxatin; Taxotere

Eligibility Criteria

Inclusion Criteria

1. Must provide written informed consent.

2. Must be ≥18 years of age.

3. Must have life expectancy of greater than 3 months.

4. Must have pathologically proven Siewert type II or III GEJ or gastric adenocarcinoma from the main tumor or local lymph nodes (pre-neoadjuvant chemo).

5. Stage cT2 or higher, any N and M0, are eligible for the study.

6. 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.

7. Must be a candidate for neoadjuvant chemotherapy.

8. Must be a candidate for curative surgical approach.

9. Must have an ECOG performance status 0-2.

10. 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.

11. 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.

Exclusion Criteria

1. 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.

2. Seiwert type I GEJ cancer

3. Subjects with clinical evidence of metastatic disease.

4. Biopsy proven metastatic disease (excluding regional lymph nodes)

5. Prior chemotherapy for gastric cancer or GEJ cancer

6. 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.

7. 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.

8. Subjects unwilling or unable to comply with the protocol or provide written informed consent.

9. Any medical condition that, in the opinion of the investigator, would exclude the subject from participating in this study and treatment plan.

10. ECOG > 2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Tannaz Armaghnay

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tannaz Armaghany, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine Medical Center - McNair Campus

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Baylor St. Luke's Medical Center

Houston, Texas, United States

Ben Taub Hospital

Houston, Texas, United States

Harris Health System- Smith Clinic

Houston, Texas, United States

Countries

United States

Other Identifiers

H-50068

Identifier Type: -

Identifier Source: org_study_id