Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002570
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
1999-11-01
Brief Title:
Immediate Compared With Delayed Chemotherapy in Advanced Colorectal Cancer Without Signs or Symptoms of Disease
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Study of Immediate Versus Delayed Chemotherapy for Asymptomatic Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known which treatment regimen is more effective for colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of immediate with delayed fluorouracil plus leucovorin in treating patients with advanced colorectal cancer without signs or symptoms of disease
PURPOSE Randomized phase III trial to compare the effectiveness of immediate with delayed fluorouracil plus leucovorin in treating patients with advanced colorectal cancer without signs or symptoms of disease
Detailed Description:
OBJECTIVES I Compare survival and quality of life in asymptomatic patients with advanced colorectal cancer randomized to immediate fluorouracilleucovorin 5-FUCF vs 5-FUCF delayed until onset of symptoms
OUTLINE Randomized unblinded study Arm I Single-Agent Chemotherapy with Drug Modulation Fluorouracil 5-FU NSC-19893 with Leucovorin calcium CF NSC-3590 Arm II Observation followed by Single-Agent Chemotherapy with Drug Modulation Clinical observation until symptomatic followed by 5-FU with CF
PROJECTED ACCRUAL 144 patients will be entered over 4 years
OUTLINE Randomized unblinded study Arm I Single-Agent Chemotherapy with Drug Modulation Fluorouracil 5-FU NSC-19893 with Leucovorin calcium CF NSC-3590 Arm II Observation followed by Single-Agent Chemotherapy with Drug Modulation Clinical observation until symptomatic followed by 5-FU with CF
PROJECTED ACCRUAL 144 patients will be entered over 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-CO10 | OTHER | None | None |
| NCCTG-JCO10 | OTHER | None | None |
| NCI-V94-0463 | OTHER_GRANT | None | None |
| CDR0000063607 | OTHER | PDQ | None |