Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06028737
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-08-26
Brief Title:
Total Neoadjuvant Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer
Sponsor:
Ukrainian Society of Clinical Oncology
Organization:
Ukrainian Society of Clinical Oncology
Study Overview
Official Title:
Total Neoadjuvant Chemotherapy With 5-fluoruracil Leucovorin Oxaliplatin and Docetaxel in Locally Advanced Gastric and Gastroesophageal Junction Cancer OCTASUR Randomized Single Center Open Label Trial Phase 23
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCTASUR
Brief Summary:
The main goal of this study is to investigate the histopathological regression rate in patients with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens followed by surgery
1 8 cycles of Total Neoadjuvant ChemoTherapy TNT with 5-Fluorouracil 5-FU Leucovorin Oxaliplatin and Docetaxel FLOT followed by surgery
2 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively
1 8 cycles of Total Neoadjuvant ChemoTherapy TNT with 5-Fluorouracil 5-FU Leucovorin Oxaliplatin and Docetaxel FLOT followed by surgery
2 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively
Detailed Description:
758 participants with resectable locally advanced gastric and gastroesophageal Siewert 2 3 adenocarcinoma T3-4b N1-3 M0 with no history of previous treatment will be included in this study after reading and signing the informed consent After the initial diagnostic laparoscopy patients will be randomized into two groups in a 11 ratio with allocation to one of the two study groups
Patients who will be randomized to the first control group will receive 8 cycles of perioperative FLOT chemotherapy scheme 4 cycles before surgical treatment and 4 cycles after surgical intervention Patients who will be randomized to the second study group will receive 8 cycles of FLOT total neoadjuvant chemotherapy followed by surgery
Primary endpoint of the study is pathomorphological tumor response rate Secondary endpoints are perioperative morbidity and mortality surgical and chemotherapeutic complications disease-free survival DFS and 1- 3- and 5-years overall survival OS quality of life during and after the treatment correlation between the pathohistological response and chemotherapy regimen
Patients who will be randomized to the first control group will receive 8 cycles of perioperative FLOT chemotherapy scheme 4 cycles before surgical treatment and 4 cycles after surgical intervention Patients who will be randomized to the second study group will receive 8 cycles of FLOT total neoadjuvant chemotherapy followed by surgery
Primary endpoint of the study is pathomorphological tumor response rate Secondary endpoints are perioperative morbidity and mortality surgical and chemotherapeutic complications disease-free survival DFS and 1- 3- and 5-years overall survival OS quality of life during and after the treatment correlation between the pathohistological response and chemotherapy regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None