Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05184803
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-12-21
Brief Title:
A Phase 2 Study of Neoadjuvant Docetaxel Oxaliplatin S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
A Phase 2 Study of Neoadjuvant Docetaxel Oxaliplatin S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
Gastric cancer is the fifth most common carcinoma in the world and cancer-related deaths rank third It is one of the main causes of death from cancer in Korea The cure method for gastric cancer is radical resection but in most patients radical resection is impossible due to local infiltration or peripheral organ or distant metastasis Many assisted chemotherapy has been studied to improve survival rate and in East Asia assisted chemotherapy after complete D2 resection is the standard treatment In the West on the other hand preoperative chemotherapy and postoperative assisted chemotherapy are currently standard treatments However due to the limited effect of adjuvant chemotherapy it has been reported that better clinical course can be improved by increasing anticancer intensity
In this context a large number of prior chemotherapy have been attempted and prior chemotherapy has several potential effects as follows 1 Improvement of R0 resection rate due to reduced primary cancer size 2 early treatment for micro metastasis 3 evaluation of treatment response rate in patients with measurable lesions and 4 unnecessary laparotomy can be avoided in patients with biologically aggressive diseases
Based on the efficacy of chemotherapy in the combination of docetaxel fluoropyrimidine and platinum in metastatic gastric cancer the investigators conducted a preceding auxiliary anti-cancer clinical trial of docetaxel capecitabine and cisplatin in advanced gastric cancer patients who could not be completely resected by surgery DXP was performed 4-6 cycles before surgery with the recommended dose in phase 1-2 In a total of 49 patients R0 resection was performed in 31 63 and among patients R0 resection was improved in cases where resection was not possible due to local infiltration 71 and in cases where para-aortic node metastasis was performed 73
We have reported that docetaxel oxaliplatin and S-1 chemotherapy DOS as preoperative adjuvant therapy can be safely administered in combination with D2 gastrectomy and postoperative adjuvant therapy S-1 in potentially resectable local progressive gastric cancer patients R0 resection was achieved in 976 of patients and pathological complete remission was observed in 195 Based on this a phase 3 PRODIGY study was performed to evaluate the benefit of S-1 CSC group as a preoperative prior chemotherapy compared to S-1 SC group as a postoperative adjuvant therapy in gastric cancer of cT23N or cT4Nany stage and 075 of the CSC group was administered HR In the patient group undergoing surgery the R0 resection rate was 95 in the CSC group and 84 in the SC group In the CSC group the pathological complete remission rate was 104
Based on these results a clinical trial of DOS as a preoperative chemotherapy was planned for progressive gastric cancer that could not be resected due to local progression or metastasis limited to remote lymph nodes
Primary goal Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial
Secondary objective safety evaluation overall survival period progression-free survival period pathological complete remission rate and investigation of biological markers
In this context a large number of prior chemotherapy have been attempted and prior chemotherapy has several potential effects as follows 1 Improvement of R0 resection rate due to reduced primary cancer size 2 early treatment for micro metastasis 3 evaluation of treatment response rate in patients with measurable lesions and 4 unnecessary laparotomy can be avoided in patients with biologically aggressive diseases
Based on the efficacy of chemotherapy in the combination of docetaxel fluoropyrimidine and platinum in metastatic gastric cancer the investigators conducted a preceding auxiliary anti-cancer clinical trial of docetaxel capecitabine and cisplatin in advanced gastric cancer patients who could not be completely resected by surgery DXP was performed 4-6 cycles before surgery with the recommended dose in phase 1-2 In a total of 49 patients R0 resection was performed in 31 63 and among patients R0 resection was improved in cases where resection was not possible due to local infiltration 71 and in cases where para-aortic node metastasis was performed 73
We have reported that docetaxel oxaliplatin and S-1 chemotherapy DOS as preoperative adjuvant therapy can be safely administered in combination with D2 gastrectomy and postoperative adjuvant therapy S-1 in potentially resectable local progressive gastric cancer patients R0 resection was achieved in 976 of patients and pathological complete remission was observed in 195 Based on this a phase 3 PRODIGY study was performed to evaluate the benefit of S-1 CSC group as a preoperative prior chemotherapy compared to S-1 SC group as a postoperative adjuvant therapy in gastric cancer of cT23N or cT4Nany stage and 075 of the CSC group was administered HR In the patient group undergoing surgery the R0 resection rate was 95 in the CSC group and 84 in the SC group In the CSC group the pathological complete remission rate was 104
Based on these results a clinical trial of DOS as a preoperative chemotherapy was planned for progressive gastric cancer that could not be resected due to local progression or metastasis limited to remote lymph nodes
Primary goal Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial
Secondary objective safety evaluation overall survival period progression-free survival period pathological complete remission rate and investigation of biological markers
Detailed Description:
None
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