Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02409472
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2015-04-01
Brief Title:
Intensive Versus Minimal Surveillance of Patients With Resected Dukes B2-C Colorectal Carcinoma
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Mario Negri Institute for Pharmacological Research
Study Overview
Official Title:
A Randomized Trial Of Intensive Versus Minimal Surveillance Of Patients With Resected Dukes B2-C Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-04
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:
GILDA
Brief Summary:
Dukes B2-C colorectal cancer patients who had no evidence of disease at the end of their front line treatment surgery and adjuvant radio-chemotherapy if indicated are eligible for the trial and randomized to two different surveillance programs These programs differ greatly in the frequency of diagnostic imaging They have similar schedules of physical examinations and carcinoembryonic antigen CEA assessments Patients will receive baseline and yearly health-related quality of life HR-QoL questionnaires Primary outcomes are overall survival and QoL
Detailed Description:
Minimal program for colon cancer Office visit and CEA at 481216202430364248 and 60 months Colonoscopy at 12 and 48 months Liver echography at 8 and 20 months
Intensive program for colon cancer Office visit CBC CEACA 199 at 481216202430364248 and 60 months Colonoscopy at 12 24 36 48and 60 months Liver echography at 481216243648 and 60 months Chest X-ray at 12243648and 60 months
Abdominal-pelvis CT as an alternative to echography was a 2 level exam only doubtful results of physical examination or echography increasing levels of CEA predictable poor sensitivity of echography due to obesity or other anatomic-clinical conditions
Intensive program for colon cancer Office visit CBC CEACA 199 at 481216202430364248 and 60 months Colonoscopy at 12 24 36 48and 60 months Liver echography at 481216243648 and 60 months Chest X-ray at 12243648and 60 months
Abdominal-pelvis CT as an alternative to echography was a 2 level exam only doubtful results of physical examination or echography increasing levels of CEA predictable poor sensitivity of echography due to obesity or other anatomic-clinical conditions
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