Ignite Creation Date:
2024-05-06 @ 4:03 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02442362
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2015-05-10
Brief Title:
TOF Versus SOX in Metastatic Gastric Cancer
Sponsor:
The First Peoples Hospital of Changzhou
Organization:
The First Peoples Hospital of Changzhou
Study Overview
Official Title:
PaclitaxelOxaliplatinFluorouracil TOF Regimen Versus S-1Oxaliplatin SOX Regimen Metastatic Gastric Cancer Patients
Status:
COMPLETED
Status Verified Date:
2015-05
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:
This study was designed to compare the efficacy and safety of aclitaxeloxaliplatinfluorouracil TOF regimen and S-1oxaliplatin SOX regimen for metastatic gastric cancer GC patients
Detailed Description:
Gastric carcinoma ranks second among the most common causes of cancer deaths worldwide with especial high prevalence in Asia Gastric cancer is the third most common cancer in China and the incidence rate and death rate of gastric cancer in Jiangsu Province are especially higher than the national average Surgical resection is the preferred treatment for gastric cancer but approximately two-thirds of patients have metastatic disease at the time of diagnosis Prognosis in these patients is poor with a median survival time of 3 to 5 months without treatment and a reported 5-year survival rate of 94 Even receiving curative gastrectomy 60 of mGC patients develop local recurrences or distant metastasis
For advanced-stage patients with inoperable gastric tumors chemotherapy is considered the most effective treatment option and the efficacy of postoperative chemotherapy has been acknowledged However a worldwide consensus on standard chemotherapy regimens has yet to be established The prognosis has gradually improved because of advances in chemotherapy regimens but is not yet satisfactoryAmong various regimens the combinations of paclitaxeloxaliplatinfluorouracil TOF regimen and S-1oxaliplatin SOX regimen have become two important ones
Paclitaxel can bind to microtubules and induces hyperstabilization leading to cell cycle arrest and apoptosis The response rate of GC patients to paclitaxel is 20-25 Oxaliplatin is a third-generation diaminocyclohexane platinum compound which has a wide range of antitumor activities appearing to have a better safety profile than cisplatin The response rate of mGC patients to FOLFOX-4 regimen is 38-43 S-1 is an oral anti-cancer agent composed of tegafur 5-chloro-24-dihydroxypyridine and oteracil potassium The applying of S-1 as adjuvant chemotherapy for mGC can improve the overall survival OS and relapse-free survival A meta-analysis showed OS favored S-1-based chemotherapy over 5-FU-based chemotherapy in mGC S-1 plus oxaliplatin SOX have showed non-inferiority to S-1 plus cisplatin in PFS and that the treatment was well tolerated in patients with mGC
No study is available comparing the efficacy and safety of TOF and SOX regimens So the investigators performed the present randomized controlled study to compare the efficacy and safety of the two regimens in mGC patients
For advanced-stage patients with inoperable gastric tumors chemotherapy is considered the most effective treatment option and the efficacy of postoperative chemotherapy has been acknowledged However a worldwide consensus on standard chemotherapy regimens has yet to be established The prognosis has gradually improved because of advances in chemotherapy regimens but is not yet satisfactoryAmong various regimens the combinations of paclitaxeloxaliplatinfluorouracil TOF regimen and S-1oxaliplatin SOX regimen have become two important ones
Paclitaxel can bind to microtubules and induces hyperstabilization leading to cell cycle arrest and apoptosis The response rate of GC patients to paclitaxel is 20-25 Oxaliplatin is a third-generation diaminocyclohexane platinum compound which has a wide range of antitumor activities appearing to have a better safety profile than cisplatin The response rate of mGC patients to FOLFOX-4 regimen is 38-43 S-1 is an oral anti-cancer agent composed of tegafur 5-chloro-24-dihydroxypyridine and oteracil potassium The applying of S-1 as adjuvant chemotherapy for mGC can improve the overall survival OS and relapse-free survival A meta-analysis showed OS favored S-1-based chemotherapy over 5-FU-based chemotherapy in mGC S-1 plus oxaliplatin SOX have showed non-inferiority to S-1 plus cisplatin in PFS and that the treatment was well tolerated in patients with mGC
No study is available comparing the efficacy and safety of TOF and SOX regimens So the investigators performed the present randomized controlled study to compare the efficacy and safety of the two regimens in mGC patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None