Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Docetaxel

Oxaliplatin

Leucovorin

Antibodies

Antibodies, Monoclonal

Durvalumab

Immunoglobulins

Antineoplastic Agents, Immunological

A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

FLOT chemotherapy

This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).

This study investigates treatment of durvalumab or placebo therapy combined with FLOT chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery (neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer, and also to better understand the studied disease and associated health problems.

Randomized, Double-blind, Placebo-controlled study

Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

EFS is the time from date of randomization until the date of disease progression or death.

Overall survival is length of time from randomization until the date of death due to any cause.

pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.

AstraZeneca

Rare Diseases

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Tegafur

Fluorouracil

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

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

FLOT Chemotherapy

Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)

SOX Chemotherapy

Birendra Kumar Sah, PH D

Chen Li, PH D

Zhenggang Zhu, PH D

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

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.

Randomly assigned(1:1) either to FLOT or SOX group.

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

Dragon III- Phase 2: The Preliminary Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: Open-label, Randomized Controlled Trial

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

1. Overall survival Time from randomization to death from disease
2. Disease free survival Time from randomization to relapse or death from disease

Ruijin Hospital

Principal Investigator

A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered

A cycle consist of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous

Repeated every 15th day

Three drug Chemotherapy: 5-FU+CF+Docetaxel+Oxaliplatin

FLOT Chemotherpy Regimen

Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered

A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)

Repeated every 21st day

Two drug Chemotherapy: Oxaliplatin+TGO

SOX Chemotherapy Regimen

A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered

A cycle consists of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous

Repeated every 15th day

Three drug Chemotherapy: 5-FU+Leucovorin+Docetaxel+Oxaliplatin

Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered

A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil (TGO) potassium capsule 80mg/M2 oral (twice daily)

Repeated every 21st day

Two drug Chemotherapy: Oxaliplatin+TGO

Total

<=60

61-70

71-80

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

China

Region of Enrollment

This is a preliminary result of phase II study with inadequate sample numbers. A phase III multi center randomised controlled trial is necessary to justify these results.

Dr BIRENDRA KUMAR SAH

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

Overall Survival (OS) Disease Free Survival (DFS)

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

Three drug Chemotherapy: 5-FU+Leucovorin+Docetaxel+Oxaliplatin

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer	NCT04592913	Gastrointestina... Esophagogastric...	Durvalumab FLOT chemothera...	18 Years - 200 Years	AstraZeneca
Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer	NCT03636893	Gastric Cancer Chemotherapy Ef...	FLOT Chemothera... SOX Chemotherap...	18 Years - 80 Years	Ruijin Hospital
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer	NCT04592913	Gastrointestina... Esophagogastric...	Durvalumab FLOT chemothera...	18 Years - 200 Years	AstraZeneca

Spots Global Cancer Trial Database for flot chemotherapy