Colorectal CancerGILDANCT02409472
Intensive Versus Minimal Surveillance of Patients With Resected Dukes B2-C Colorectal Carcinoma
A study testing surveillance program after completion of primary treatment in people with Colorectal Cancer and Surveillance, run by Mario Negri Institute for Pharmacological Research.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Surveillance
- What is being tested?
- surveillance program after completion of primary treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,242 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: A Randomized Trial Of Intensive Versus Minimal Surveillance Of Patients With Resected Dukes B2-C Colorectal Carcinoma
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.
Read the detailed 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)
- Conditions
- Colorectal Cancer, Surveillance
- Being tested
- surveillance program after completion of primary treatment
- Keywords
- randomized clinical trial
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveillance program after completion of primary treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| minimal surveillance | Other | 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. Receives: Other: surveillance program after completion of primary treatment |
| intensive surveillance | Other | Intensive program for colon cancer: Office visit, complet blood count (CBC), CEA+ Carbohydrate Antigen (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. Receives: Other: surveillance program after completion of primary treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause
Measured: 5-year OS
Health Related Quality of Life
mean scores for Short Form Health Status Survey (SF)12 and Psychological General Well-Being (PGWB) questionnaires
Measured: Yearly assessment over 5 years
Secondary outcomes (1)
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
Measured: 5-year DFS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startApr 1998
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,242 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Andreoni, MD, Study chair, European Institute of Oncology, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409472
- Sponsor's protocol ID
- GILDA
- Acronym
- GILDA
- Status last verified
- Apr 2015
- First submitted
- 1 Apr 2015
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosati G, Ambrosini G, Barni S, Andreoni B, Corradini G, Luchena G, Daniele B, Gaion F, Oliverio G, Duro M, Martignoni G, Pinna N, Sozzi P, Pancera G, Solina G, Pavia G, Pignata S, Johnson F, Labianca R, Apolone G, Zaniboni A, Monteforte M, Negri E, Torri V, Mosconi P, Fossati R; GILDA working group. A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma. Ann Oncol. 2016 Feb;27(2):274-80. doi: 10.1093/annonc/mdv541. Epub 2015 Nov 16.
PubMed 26578734
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Of Intensive Versus Minimal Surveillance Of Patients With Resected Dukes B2-C Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT02409472
- Acronym / sponsor ID
- GILDA / GILDA
- Conditions
- Colorectal Cancer, Surveillance
- Keywords
- randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,242 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Apr 1998
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimal surveillance | Other | Other: surveillance program after completion of primary treatmentMinimal 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 surveillance | Other | Other: surveillance program after completion of primary treatmentIntensive program for colon cancer: Office visit, complet blood count (CBC), CEA+ Carbohydrate Antigen (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveillance program after completion of primary treatmentThese 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. | Other | intensive surveillance, minimal surveillance |
Primary outcome
Overall Survival (OS)
Time frame: 5-year OS
OS is defined as the time from randomization to death from any cause
Health Related Quality of Life
Time frame: Yearly assessment over 5 years
mean scores for Short Form Health Status Survey (SF)12 and Psychological General Well-Being (PGWB) questionnaires
1 secondary outcome
Disease free survival (DFS)
Time frame: 5-year DFS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Derived from this study: PubMed 26578734Rosati G, Ambrosini G, Barni S, Andreoni B, Corradini G, Luchena G, Daniele B, Gaion F, Oliverio G, Duro M, Martignoni G, Pinna N, Sozzi P, Pancera G, Solina G, Pavia G, Pignata S, Johnson F, Labianca R, Apolone G, Zaniboni A, Monteforte M, Negri E, Torri V, Mosconi P, Fossati R; GILDA working group. A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma. Ann Oncol. 2016 Feb;27(2):274-80. doi: 10.1093/annonc/mdv541. Epub 2015 Nov 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Andreoni, MD study chair
European Institute of Oncology, Milan, Italy
Questions about this trial
What is this clinical trial studying?
A study testing surveillance program after completion of primary treatment in people with Colorectal Cancer and Surveillance, run by Mario Negri Institute for Pharmacological Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 5-year OS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.