NCT04384601

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P25-P50 for phase_3 gastric-cancer

Timeline
15mo left

Started Sep 2021

Typical duration for phase_3 gastric-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Sep 2021Sep 2027

First Submitted

Initial submission to the registry

May 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Expected
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

May 8, 2020

Last Update Submit

July 15, 2021

Conditions

Gastric CancerNeoadjuvant Chemotherapy

Keywords

Gastric CancerGastric AdenocarcinomaStomach Cancer, AdenocarcinomaChemotherapy EffectNeoadjuvant chemotherapy

Outcome Measures

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

    Upto three months

Secondary Outcomes (2)

  • Overall Survival (OS)

    Five years

  • Disease free survival (DFS)

    Three years

Study Arms (2)

SOX Chemotherapy

EXPERIMENTAL

Three preoperative and three postoperative cycles of SOX chemotherapy A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day

Drug: Chemotherapy

FLOT Chemotherapy

ACTIVE COMPARATOR

Four preoperative and four postoperative cycles of FLOT chemotherapy A cycle consist of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via intravenous peripherally inserted central venous catheter(PICC) for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous Repeated every 15th day

Drug: Chemotherapy

Interventions

ChemotherapyDRUG

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

Also known as: FLOT chemotherapy, SOX chemotherapy
FLOT ChemotherapySOX Chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Written informed consent

You may not qualify if:

  • 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
  • Malignant secondary disease
  • Prior chemo or radio therapy
  • Known contraindications or hypersensitivity for planned chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Stomach NeoplasmsAdenocarcinoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Birendra K Sah, PH D

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

  • Chen Li, PH D

    Ruijin Hospital

    STUDY DIRECTOR

  • Zhenggang Zhu, PH D

    Ruijin Hospital

    STUDY CHAIR

Central Study Contacts

Birendra K Sah, Ph D

CONTACT

0086-13817516354rjsurgeon@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 12, 2020

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion (Estimated)

September 1, 2027

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)