Phase III Study OF the Gastric Surgery on Advanced Stage Gastric Cancer
|ClinicalTrials.gov Identifier: NCT00260884|
Recruitment Status : Completed
First Posted : December 2, 2005
Last Update Posted : December 2, 2005
|First Submitted Date ICMJE||December 1, 2005|
|First Posted Date ICMJE||December 2, 2005|
|Last Update Posted Date||December 2, 2005|
|Study Start Date ICMJE||October 1993|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Phase III Study OF the Gastric Surgery on Advanced Stage Gastric Cancer|
|Official Title ICMJE||Phase III Study of the Effect of Radical Gastric Surgery Versus Conventional Surgery on Recurrence and Survival in Patients With Advanced Stage Gastric Cancer.|
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 0.05 level and power of 0.8 using a one tailed test.
We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.
* TREATMENT PLAN
Patients are randomized intraoperatively into arm I (conventional [R0/R1] gastrectomy) or arm II (extended radical [R3] lymph node dissection).
Arm I: Resection of stomach, greater omentum, lesser omentum, and adjacent organ(s) 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).
For patients who had gastric cancer recurrence after gastrectomy, chemotherapy with cisplatin、 5-FU、Leucovorin will be given.
Cisplatin 20mg/m2 5-FU 450 mg/m2 Leucovorin 90 mg/m2
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 WBC<4000/dl immediately before treatment). Reduce dose of subsequent cycles of 5-FU by 20% if WBC nadir <1000/dl.
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 > 2mg/dl.
Duration of treatment： Continue treatment for patients until disease progression.
* DATA AND PROTOCOL MANAGEMENT 10.1 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
10.2 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 Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Gastric Cancer|
|Intervention ICMJE||Behavioral: conventional gastrectomy or radical lymph node dissection|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||August 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||20 Years to 75 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT00260884|
|Other Study ID Numbers ICMJE||A1293|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Health Research Institutes, Taiwan|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Health Research Institutes, Taiwan|
|Verification Date||December 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP