Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer
Recruiting
Phase 2
Phase 3
Interventional Study
Gastric Cancer
Stomach Cancer
GastroEsophageal Cancer
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Advanced Gastric Adenocarcinoma
Gastric Neoplasm
Stomach Neoplasm
Gastrointestinal Cancer
Advanced Gastroesophageal Junction Adenocarcinoma
Advanced Gastric Carcinoma
Chemotherapy
Gastrectomy
Gastrectomy for Gastric Cancer
Gastric Resection
Gastric (Cardia, Body) Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Ukrainian Society of Clinical Oncology · Other
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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. …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 …
Contacts