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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02409472
Other study ID # GILDA
Secondary ID
Status Completed
Phase N/A
First received April 1, 2015
Last updated April 8, 2015
Start date April 1998
Est. completion date December 2012

Study information

Verified date April 2015
Source Mario Negri Institute for Pharmacological Research
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

Minimal program for colon cancer: Office visit and CEA at 4,8,12,16,20,24,30,36,42,48, and 60 months. Colonoscopy at 12, and 48 months. Liver echography* at 8, and 20 months.

Intensive program for colon cancer: Office visit, CBC, CEA+CA 19.9 at 4,8,12,16,20,24,30,36,42,48, and 60 months. Colonoscopy at 12, 24, 36, 48,and 60 months. Liver echography* at 4,8,12,16,24,36,48, and 60 months. Chest X-ray at 12,24,36,48,and 60 months.

* Abdominal-pelvis C.T., 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)


Recruitment information / eligibility

Status Completed
Enrollment 1242
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with histologically proven adenocarcinoma of the colon or rectum with Dukes Astler-Coller modification stage B2-C who had been treated with curative intent (radical excision ± adjuvant radio-chemotherapy) .

- Eligible patients had to be free of known cancer prior to study entry as attested by negative results of endoscopy, liver ultrasonography, chest roentgenography and serum CEA level performed < 4 months before randomization

Exclusion Criteria:

- Inability to undergo testing (disability, allergy to contrast agents, etc.) and patients geographically not amenable to full follow-up.

- Patients enrolled onto any other research protocol that requires strict adherence to any specific follow-up practice.

- A history of any previous malignancy in the last 10 years (other than carcinoma in situ of the cervix or non-melanoma skin cancer).

- No informed consent to participate in the trial according to local regulatory guidelines.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
surveillance program after completion of primary treatment
These are two different surveillance programs for Dukes B2-C colorectal cancer patients who have no evidence of disease at the end of their front line treatment (surgery and adjuvant radio-chemotherapy, if indicated). These programs differ greatly in the frequency of diagnostic imaging. They had similar schedules of physical examinations and carcinoembryonic antigen (CEA) assessments.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mario Negri Institute for Pharmacological Research

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) OS is defined as the time from randomization to death from any cause 5-year OS No
Primary Health Related Quality of Life mean scores for Short Form Health Status Survey (SF)12 and Psychological General Well-Being (PGWB) questionnaires Yearly assessment over 5 years No
Secondary Disease free survival (DFS) DFS is defined as the time from randomization to the earliest occurrence of progression or second primary colorectal cancer in both groups 5-year DFS No
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