Preventive HIPEC in combination with perioperative FLOT versus FLOT alone for resectable diffuse type gastric and gastroesophageal junction type II/III adenocarcinoma - the phase III "PREVENT"- (FLOT9) trial of the AIO /CAOGI /ACO.
Adenocarcinoma
/ drug therapy
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Cisplatin
/ administration & dosage
Docetaxel
Drug Administration Schedule
Esophagogastric Junction
Fluorouracil
/ administration & dosage
Gastrectomy
/ methods
Humans
Hyperthermic Intraperitoneal Chemotherapy
/ methods
Leucovorin
/ administration & dosage
Neoadjuvant Therapy
/ methods
Neoplasm Seeding
Oxaliplatin
Peritoneal Neoplasms
/ prevention & control
Preoperative Care
/ methods
Progression-Free Survival
Stomach Neoplasms
/ drug therapy
Cisplatin
FLOT- regimen
Gastrectomy
Gastric cancer
Gastroesophageal junction cancer
HIPEC
Hyperthermic intraperitoneal chemotherapy
Lauren- classification
Peritoneal carcinomatosis
Quality of life
Signet ring cells
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
29 Oct 2021
29 Oct 2021
Historique:
received:
29
07
2021
accepted:
11
10
2021
entrez:
30
10
2021
pubmed:
31
10
2021
medline:
8
2
2022
Statut:
epublish
Résumé
The main reason for treatment failure after curative surgical resection of gastric cancer is intra-abdominal spread, with 40-50% peritoneal seeding as primary localization of recurrence. Peritoneal relapse is seen in 60-70% of tumors of diffuse type, compared to only 20-30% of intestinal type. Hyperthermic IntraPEritoneal Chemoperfusion (HIPEC) is an increasingly used therapy method for patients with peritoneal metastases. The preventive use of HIPEC could represent an elegant approach for patients (pts) before macroscopic peritoneal seeding, since pts. with operable disease are fit and may have potential risk of microscopic involvement, thus having a theoretical chance of cure with HIPEC even without the need for cytoreduction. No results from a PCRT from the Western hemisphere have yet been published. This is a multicenter, randomized, controlled, open-label study including a total of 200 pts. with localized and locally advanced diffuse or mixed type (Laurens's classification) adenocarcinoma of the stomach and Type II/III GEJ. All enrolled pts. will have received 3-6 pre-operative cycles of biweekly FLOT (Docetaxel 50 mg/m If the PREVENT concept proves to be effective, this could potentially lead to a new standard of therapy. On the contrary, if the outcome is negative, pts. with gastric cancer and no peritoneal involvement will not be treated with HIPEC during surgery. The study is registered on June 25th, 2020 under ClinicalTrials.gov Identifier: NCT04447352 ; EudraCT: 2017-003832-35 .
Sections du résumé
BACKGROUND
BACKGROUND
The main reason for treatment failure after curative surgical resection of gastric cancer is intra-abdominal spread, with 40-50% peritoneal seeding as primary localization of recurrence. Peritoneal relapse is seen in 60-70% of tumors of diffuse type, compared to only 20-30% of intestinal type. Hyperthermic IntraPEritoneal Chemoperfusion (HIPEC) is an increasingly used therapy method for patients with peritoneal metastases. The preventive use of HIPEC could represent an elegant approach for patients (pts) before macroscopic peritoneal seeding, since pts. with operable disease are fit and may have potential risk of microscopic involvement, thus having a theoretical chance of cure with HIPEC even without the need for cytoreduction. No results from a PCRT from the Western hemisphere have yet been published.
METHODS
METHODS
This is a multicenter, randomized, controlled, open-label study including a total of 200 pts. with localized and locally advanced diffuse or mixed type (Laurens's classification) adenocarcinoma of the stomach and Type II/III GEJ. All enrolled pts. will have received 3-6 pre-operative cycles of biweekly FLOT (Docetaxel 50 mg/m
DISCUSSION
CONCLUSIONS
If the PREVENT concept proves to be effective, this could potentially lead to a new standard of therapy. On the contrary, if the outcome is negative, pts. with gastric cancer and no peritoneal involvement will not be treated with HIPEC during surgery.
TRIAL REGISTRATION
BACKGROUND
The study is registered on June 25th, 2020 under ClinicalTrials.gov Identifier: NCT04447352 ; EudraCT: 2017-003832-35 .
Identifiants
pubmed: 34715810
doi: 10.1186/s12885-021-08872-8
pii: 10.1186/s12885-021-08872-8
pmc: PMC8555172
doi:
Substances chimiques
Oxaliplatin
04ZR38536J
Docetaxel
15H5577CQD
Cisplatin
Q20Q21Q62J
Leucovorin
Q573I9DVLP
Fluorouracil
U3P01618RT
Banques de données
ClinicalTrials.gov
['NCT04447352']
Types de publication
Clinical Trial Protocol
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1158Subventions
Organisme : deutsche krebshilfe
ID : 70113137
Informations de copyright
© 2021. The Author(s).
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