Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260884
Status:
COMPLETED
Last Update Posted:
2005-12-02
First Post:
2005-12-01
Brief Title:
Phase III Study OF the Gastric Surgery on Advanced Stage Gastric Cancer
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
Phase III Study of the Effect of Radical Gastric Surgery Versus Conventional Surgery on Recurrence and Survival in Patients With Advanced Stage Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2005-12
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:
OBJECTIVES To determine in a prospective randomized clinical trial the effect of extended lymph node dissection R3 gastrectomy versus conventional surgery R01 gastrectomy on tumor recurrence and survival in Chinese patients with advanced cancer of the stomach adenocarcinoma invasion beyond submucosa
STATISTICAL CONSIDERATIONS The major end points are disease free survival and survival The log-rank test will be used as analytic method on disease-free survival and overall durvival The follow-up time after treatment is five years
Previous experience provides an estimation of a 20 5-year survival rate with conventional surgery for gastric cancer Assuming that this new treatment radical surgery may increase the 5-year survival rate to 40 we estimate that 118 evaluable patients are required to detected a significance at a of 005 level and power of 08 using a one tailed test
We expect to enter 50 patients per year and finish accrual of patient within 25 years
STATISTICAL CONSIDERATIONS The major end points are disease free survival and survival The log-rank test will be used as analytic method on disease-free survival and overall durvival The follow-up time after treatment is five years
Previous experience provides an estimation of a 20 5-year survival rate with conventional surgery for gastric cancer Assuming that this new treatment radical surgery may increase the 5-year survival rate to 40 we estimate that 118 evaluable patients are required to detected a significance at a of 005 level and power of 08 using a one tailed test
We expect to enter 50 patients per year and finish accrual of patient within 25 years
Detailed Description:
TREATMENT PLAN
Patients are randomized intraoperatively into arm I conventional R0R1 gastrectomy or arm II extended radical R3 lymph node dissection
Arm I Resection of stomach greater omentum lesser omentum and adjacent organs when the primary tumor invaded directly A total or distal subtotal gastrectomy is decided by the proximal distance from cardia to the tumor A margin of 3 cm was required for well-defined Borrmann I or II tumors and of 5 cm for ill-defined Borrmann III or IV tumors When a total gastrectomy is performed the distal pancreas and spleen should be preserved unless there is direct invasion into these organs The left gastric artery should not be ligated at its origin but distal to its bifurcation into ascending and descending branches
Arm II The procedure are the same as in Arm I additionally extended lymph node dissection includes dissection of the N1 N2 and N3 nodes These groups N are comprised of lymph node stations which depended on the location of the primary tumors Fig 1
1 For N2 dissection the left gastric artery is ligated at its origin to facilitate the dissection of No7 If a total gastrectomy is indicated a splenectomy is essential for the dissection of station No 10 and a distal pancreatectomy for the dissection of station No11 Combined resection of these adjacent organs is not performed during a distal subtotal gastrectomy
2 If the primary cancer is located at the middle or lower third of stomach No1 nodes at right cardiac and 11 nodes along the splenic artery are excised routinely for frozen section before gastric resection If no cancer metastasis is seen in both No1 and 11 lymph nodes is performed If only No 1 lymph nodes is positive for cancer metastasis total gastrectomy is performed instead of distal subtotal resection If No 11 lymph nodes are positive splenectomy and distal pancreatectomy are performed in addition to the radical resection of the stomach and lymph nodes
3 For N3 dissection No 12 nodes in the hepatoduodenal ligament No 13 nodes at retropancreatic region and No 14 nodes at the root of mesentery are dissected
For patients who had gastric cancer recurrence after gastrectomy chemotherapy with cisplatin 5-FULeucovorin will be given
Cisplatin 20mgm2 5-FU 450 mgm2 Leucovorin 90 mgm2
The above three drugs to be given in 500ml of normal saline and infused intravenously simultaneously over 96 hours and repeated every 3 weeks 21days
Dose modification Delay treatment for one week if WBC4000dl immediately before treatment Reduce dose of subsequent cycles of 5-FU by 20 if WBC nadir 1000dl
Delay treatment for one week if there is oral mucositis or diarrhea immediately before treatment Reduce dose of subsequent cycles of 5-FU by 10 for grade 2 and 20 for grade 3 or 4 mucositis or diarrhea
Stop treatment for any grade 4 non-hematological toxicity Stop cisplatin treatment if serum creatinine 2mgdl
Duration of treatment Continue treatment for patients until disease progression
DATA AND PROTOCOL MANAGEMENT 101 Registration randomization will be performed by the Cancer Clinical Trial Operations Office by calling 789-9046 47 7852459
Quality control of the data will be performed by the Cancer Clinical Trial Operations Office Institute of Biomedical Sciences Academia Sinica
Data will be evaluated by the statistician and the study chairman before data analyzed
102 Protocol Compliance the attending physician and oncology research nurse must see each patient prior to treatment and at follow up to ensure all investigations treatment procedures and data records are done and recorded according to protocol
Patients are randomized intraoperatively into arm I conventional R0R1 gastrectomy or arm II extended radical R3 lymph node dissection
Arm I Resection of stomach greater omentum lesser omentum and adjacent organs when the primary tumor invaded directly A total or distal subtotal gastrectomy is decided by the proximal distance from cardia to the tumor A margin of 3 cm was required for well-defined Borrmann I or II tumors and of 5 cm for ill-defined Borrmann III or IV tumors When a total gastrectomy is performed the distal pancreas and spleen should be preserved unless there is direct invasion into these organs The left gastric artery should not be ligated at its origin but distal to its bifurcation into ascending and descending branches
Arm II The procedure are the same as in Arm I additionally extended lymph node dissection includes dissection of the N1 N2 and N3 nodes These groups N are comprised of lymph node stations which depended on the location of the primary tumors Fig 1
1 For N2 dissection the left gastric artery is ligated at its origin to facilitate the dissection of No7 If a total gastrectomy is indicated a splenectomy is essential for the dissection of station No 10 and a distal pancreatectomy for the dissection of station No11 Combined resection of these adjacent organs is not performed during a distal subtotal gastrectomy
2 If the primary cancer is located at the middle or lower third of stomach No1 nodes at right cardiac and 11 nodes along the splenic artery are excised routinely for frozen section before gastric resection If no cancer metastasis is seen in both No1 and 11 lymph nodes is performed If only No 1 lymph nodes is positive for cancer metastasis total gastrectomy is performed instead of distal subtotal resection If No 11 lymph nodes are positive splenectomy and distal pancreatectomy are performed in addition to the radical resection of the stomach and lymph nodes
3 For N3 dissection No 12 nodes in the hepatoduodenal ligament No 13 nodes at retropancreatic region and No 14 nodes at the root of mesentery are dissected
For patients who had gastric cancer recurrence after gastrectomy chemotherapy with cisplatin 5-FULeucovorin will be given
Cisplatin 20mgm2 5-FU 450 mgm2 Leucovorin 90 mgm2
The above three drugs to be given in 500ml of normal saline and infused intravenously simultaneously over 96 hours and repeated every 3 weeks 21days
Dose modification Delay treatment for one week if WBC4000dl immediately before treatment Reduce dose of subsequent cycles of 5-FU by 20 if WBC nadir 1000dl
Delay treatment for one week if there is oral mucositis or diarrhea immediately before treatment Reduce dose of subsequent cycles of 5-FU by 10 for grade 2 and 20 for grade 3 or 4 mucositis or diarrhea
Stop treatment for any grade 4 non-hematological toxicity Stop cisplatin treatment if serum creatinine 2mgdl
Duration of treatment Continue treatment for patients until disease progression
DATA AND PROTOCOL MANAGEMENT 101 Registration randomization will be performed by the Cancer Clinical Trial Operations Office by calling 789-9046 47 7852459
Quality control of the data will be performed by the Cancer Clinical Trial Operations Office Institute of Biomedical Sciences Academia Sinica
Data will be evaluated by the statistician and the study chairman before data analyzed
102 Protocol Compliance the attending physician and oncology research nurse must see each patient prior to treatment and at follow up to ensure all investigations treatment procedures and data records are done and recorded according to protocol
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