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Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer

ConditionsGastric CancerNeoadjuvant Chemotherapy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRuijin Hospital

About this trial

DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase 3, open label, multi-center randomized controlled study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histology confirmed non-obstructive adenocarcinoma of stomach or esophago-gastric junction.

Clinical stage: Clinical Tumor-Node-Metastasis (cTNM:) stage III

Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)

Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic and pulmonary function.

Disqualifiers

Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia

Distant metastases (including retroperitoneal lymph node)

Locally advanced inoperable disease (Clinical assessment)

Relapse of gastric cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chemotherapy

    Drug

    Perioperative chemotherapy will be administered according to description in two arms.

Treatment groups

246 Participants
are divided into 2 treatment groups
Group A: SOX ChemotherapyExperimental treatment 1 intervention
Group B: FLOT ChemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour

Tumor regression grade (TRG), Becker criteria Grade 1a :Complete tumor regression: 0% residual tumor per tumor bed Grade 1b: Subtotal tumor regression: \<10% residual tumor per tumor bed Grade 2: Partial tumor regression: 10-50% residual tumor per tumor bed Grade 3: Minimal or no tumor regression: \>50% residual tumor per tumor bed

Time frame
Upto three months

Secondary outcomes

1

Overall Survival (OS)

Overall survival Time from randomization to death from any cause

Time frame
Five years
2

Disease free survival (DFS)

Disease free survival Time from randomization to relapse or death from any cause

Time frame
Three years

Other outcomes

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: