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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status and phase

Completed
Phase 2

Conditions

Chemotherapy Effect
Gastric Cancer

Treatments

Drug: FLOT Chemotherapy
Drug: SOX Chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03636893
Dragon III

Details and patient eligibility

About

Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer patients in high volume center of China

Full description

DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase II, open label, randomised controlled study. This study will be conducted and analyzed by the Gastrointestinal department(Unit III)of the Ruijin Hospital and the project is supported by the Institute of Digestive Surgery, Shanghai, which is a state key research center. This study will be monitored by the Clinical Research Center of the Ruijin hospital (Official body which is responsible to guide and monitor all types of research at Ruijin hospital). Primary endpoint and secondary endpoint is described above. The aim of this study to obtain preliminary result and further conduct a large scale multi-center randomised controlled trial(RCT) study.

Enrollment

74 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
  • Clinical stage: cTNM: stage III or above
  • 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

Exclusion criteria

  • 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
  • Confirmed distant metastases
  • Locally advanced inoperable disease (Clinical assessment)
  • Relapse of gastric cancer
  • Malignant secondary disease
  • Prior chemo or radiotherapy
  • Inclusion in another clinical trial
  • Known contraindications or hypersensitivity for planned chemotherapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups

FLOT Chemotherapy regimen
Experimental group
Description:
A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered A cycle consists of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via an 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
Treatment:
Drug: FLOT Chemotherapy
SOX Chemotherapy regimen
Active Comparator group
Description:
Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered 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
Treatment:
Drug: SOX Chemotherapy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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