Trial Title:
A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer
NCT ID:
NCT05567835
Condition:
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Leucovorin
Docetaxel
Oxaliplatin
Fluorouracil
Conditions: Keywords:
Gastric cancer
GEJ cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15
Arm group label:
Arm A: FLOT-TNT ( Investigational Arm)
Arm group label:
Arm B: FLOT-POP ( Standard Arm)
Other name:
5-FU
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
200 mg mg/m2 IV over 2 hours Day 1,15
Arm group label:
Arm A: FLOT-TNT ( Investigational Arm)
Arm group label:
Arm B: FLOT-POP ( Standard Arm)
Other name:
LV
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
85 mg/m2 IV over 2 hours Day 1,15
Arm group label:
Arm A: FLOT-TNT ( Investigational Arm)
Arm group label:
Arm B: FLOT-POP ( Standard Arm)
Other name:
Eloxatin
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
60 mg/m2 IV over 60 minutes Day 1,15
Arm group label:
Arm A: FLOT-TNT ( Investigational Arm)
Arm group label:
Arm B: FLOT-POP ( Standard Arm)
Other name:
Taxotere
Intervention type:
Biological
Intervention name:
GSCF
Description:
Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16
Arm group label:
Arm A: FLOT-TNT ( Investigational Arm)
Arm group label:
Arm B: FLOT-POP ( Standard Arm)
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.
Criteria for 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 28 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Baylor College of Medicine Medical Center - McNair Campus
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Tannaz Armaghany, MD
Phone:
832-957-6500
Email:
Tannaz.Armaghany@bcm.edu
Facility:
Name:
Baylor College of Medicine
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Tannaz Armaghany, MD
Phone:
832-957-6500
Email:
Tannaz.Armaghany@bcm.edu
Facility:
Name:
Baylor St. Luke's Medical Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Tannaz Armaghany, MD
Phone:
832-957-6500
Email:
Tannaz.Armaghany@bcm.edu
Facility:
Name:
Ben Taub Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tannaz Armaghany, MD
Phone:
832-957-6500
Email:
Tannaz.Armaghany@bcm.edu
Facility:
Name:
Harris Health System- Smith Clinic
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tannaz Armaghany, MD
Phone:
832-957-6500
Email:
Tannaz.Armaghany@bcm.edu
Start date:
March 6, 2024
Completion date:
January 2029
Lead sponsor:
Agency:
Baylor College of Medicine
Agency class:
Other
Source:
Baylor College of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05567835
