Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004099
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
1999-12-10
Brief Title:
Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase III Study of Preoperative Chemotherapy Followed by Surgery Versus Surgery Alone in Locally Advanced Gastric Cancer cT3 and cT4NxM0
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known if surgery alone or surgery combined with chemotherapy is more effective in treating stomach cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage II stage III or stage IV stomach cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage II stage III or stage IV stomach cancer
Detailed Description:
OBJECTIVES
Compare overall survival in patients with locally advanced gastric cancer treated with surgery alone or in combination with neoadjuvant cisplatin leucovorin calcium and fluorouracil
Compare these two regimens in terms of the rate of complete resection time to progression and morbidity in these patients
Evaluate toxicity of and disease response to neoadjuvant chemotherapy in these patients
Evaluate quality of life and performance status in these patients pre- and post-surgery and compare quality of life for both regimens
OUTLINE This is a randomized open label multicenter study Patients are stratified according to center primary tumor category cT3 or cT4 localization of tumor upper third including cardia II or III vs middle and lower third gender and histological subtype intestinal vs nonintestinal Patients are randomized to one of two treatment arms
Arm I Patients receive cisplatin IV over 1 hour on days 1 15 and 29 Patients also receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1 8 15 22 29 and 36 A second course is administered beginning 2 weeks later in the absence of disease progression or unacceptable toxicity
Patients undergo resection and lymphadenectomy on days 57-63 of the second course of chemotherapy
Arm II Patients undergo resection and lymphadenectomy within 14 days of randomization
Quality of life is assessed before randomization every 3 months for 1 year and at 2 years after randomization
Patients are followed every 3 months for 1 year every 6 months for 2 years then every 3 months thereafter until death
PROJECTED ACCRUAL A total of 360 patients 180 per arm will be accrued for this study over 4 years
Compare overall survival in patients with locally advanced gastric cancer treated with surgery alone or in combination with neoadjuvant cisplatin leucovorin calcium and fluorouracil
Compare these two regimens in terms of the rate of complete resection time to progression and morbidity in these patients
Evaluate toxicity of and disease response to neoadjuvant chemotherapy in these patients
Evaluate quality of life and performance status in these patients pre- and post-surgery and compare quality of life for both regimens
OUTLINE This is a randomized open label multicenter study Patients are stratified according to center primary tumor category cT3 or cT4 localization of tumor upper third including cardia II or III vs middle and lower third gender and histological subtype intestinal vs nonintestinal Patients are randomized to one of two treatment arms
Arm I Patients receive cisplatin IV over 1 hour on days 1 15 and 29 Patients also receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1 8 15 22 29 and 36 A second course is administered beginning 2 weeks later in the absence of disease progression or unacceptable toxicity
Patients undergo resection and lymphadenectomy on days 57-63 of the second course of chemotherapy
Arm II Patients undergo resection and lymphadenectomy within 14 days of randomization
Quality of life is assessed before randomization every 3 months for 1 year and at 2 years after randomization
Patients are followed every 3 months for 1 year every 6 months for 2 years then every 3 months thereafter until death
PROJECTED ACCRUAL A total of 360 patients 180 per arm will be accrued for this study over 4 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-40954 | None | None | None |