Health TrialsbyHealthPanel

Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer

ConditionsGastric CancerStomach CancerGastroEsophageal CancerGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaAdvanced Gastric AdenocarcinomaGastric NeoplasmStomach NeoplasmGastrointestinal CancerAdvanced Gastroesophageal Junction AdenocarcinomaAdvanced Gastric CarcinomaChemotherapyGastrectomyGastrectomy for Gastric CancerGastric ResectionGastric (Cardia, Body) Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUkrainian Society of Clinical Oncology

About this trial

The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery:

1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, and Docetaxel (FLOT) followed by surgery. 2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Tumor spread according to TNM: ≥cT3 and/or ≥cN0 and M0 (except of invasion of the common hepatic artery, celiac trunk, proximal part of the splenic artery, aorta, head of the pancreas);

Performance status by Eastern Cooperative Oncology Group (ECOG): 0 - 1;

Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert type 2/3) adenocarcinoma.

Differentiation grade: G0 - G4;

Disqualifiers

Presence of another oncological disease at a different site if less than 5 years have passed since radical treatment.

Comorbidities or patient conditions that preclude the administration of chemotherapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Docetaxel

    Drug

    50mg/m2, d1, i.v., every 2 weeks

  • Oxaliplatin

    Drug

    85 mg/m², d1, i.v., every 2 weeks

  • Leucovorin

    Drug

    200 mg/m², d1, i.v., every 2 weeks

  • Fluorouracil

    Drug

    2600 mg/m²d1 i.v. every 2 weeks

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Perioperative 4+4 FLOT cyclesActive comparator 4 interventions
Group B: Total Neoadjuvant ChemoTherapy (TNT) 8 FLOT cyclesExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

All 8 planned FLOT cycles tolerance rate.

The proportion of patients receiving all planned cycles of chemotherapy and radical surgical treatment.

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

Chemotherapy toxicity rate and profile.

To determine chemotherapeutic toxicity profile, according to Common Terminology Criteria for Adverse Events (CTCEA 5.0).

Time frame
At the end of each FLOT cycle (each cycle is 14 days), up to 14 days after the last cycle.
2

Surgical complications rate.

To determine postoperative surgical complications rate and profile after the different chemotherapy regimens, according to Clavien-Dindo classification.

Time frame
30 days after surgery.
3

Median overall survival.

To determine the efficacy of TNT FLOT regimen compared to perioperative FLOT regimen by assessment of overall survival.

Time frame
From the start of treatment to the patient's death or the end of follow-up - 5 years follow-up after the last intervention.
4

Progression-free survival.

To determine the efficacy of total neoadjuvant FLOT regimen compared to perioperative FLOT regimen.

Time frame
Calculated as the time from the start of treatment to disease progression or the end of follow-up at 5 years after the treatment completion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ukrainian Society of Clinical Oncology

Lead sponsor

Source ClinicalTrials.gov
Apply now