A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients Wi… (NCT05567835) | Clinical Trial Compass
TerminatedPhase 2
A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer
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.
United States3 participantsStarted 2024-03-06
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Completion Rate of Participants Who Have Completed Their All-allocated Treatments, Either Arm A: FLOT-TNT or Arm B: FLOT-POP
Timeframe: at week 16 for Arm A and at week 24 for Arm B
✕. 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.