Colorectal CancerPhase 3NCT00199654
Positron Emission Tomography (PET) Interest in the Follow Up of Colorectal Cancer Stage II and III
A Phase 3 study testing PET in people with Colorectal Cancer, run by University Hospital, Limoges at 5 sites in France.
Trial summary
The follow up of colorectal cancer after curative surgery has to find loco-regional relapses or synchronous metastases, and to detect adenomas and new cancer on the rest of the colon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- PET
- Type of treatment
- Surgery or procedure
- How many people
- 376 participants
- Where
- 5 sitesFrance
- Study dates
- Feb 2004to Apr 2013
- Phase
- Phase 3
- 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
- Signed and dated written informed consent
- Confirmed stage II or III (TNM)
- Patient with curative surgery for colorectal adenocarcinoma
- Total digestive endoscopy prior or post surgery.
- Age > 18 years old
- Normal liver ultrasound and chest X-ray or thoraco-abdomino pelvic computed tomography (CT) scan.
- In fertile women, efficient contraception or postmenopausal patient (amenorrhea for at least 1 year)
Who cannot join
- Serious concomitant pathology
- Uncontrolled diabetes with a classical treatment (glycaemia >1.4 g/l)
- Other malignant tumour within the last 5 years (except for curatively treated basocellular carcinoma of the skin or in situ cervical carcinoma).
- Uncontrolled infection
- Women who are pregnant or lactating
- Inability to understand informed consent
- Psychological or geographic impossibility to follow up for three years.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Cancérologie et Hépato-Gastro-Entérologie
Bordeaux, 33000
Institut François Baclesse
Caen, 14000
Médecine Nucléaire
Limoges, 87000
Oncologie Médicale
Limoges, 87000
Oncologie Digestive
Marseille, 13000
About this study
Official title: PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study
The follow up of colorectal cancer after curative surgery has to find loco-regional relapses or synchronous metastases, and to detect adenomas and new cancer on the rest of the colon.
The increase of survival after relapse of the colorectal cancer depends on the possibility of curative action or after chemotherapy response.
Read more
This is a Phase III open-labeled, multicenter, multidisciplinary, randomised study, comparing 2 arms of 188 patients (i.e. 376 total patients).
Study Period (date of first inclusion/last inclusion): 3 years.
Follow Up: 3 years.
The primary objective is the evaluation of PET performance in the earlier relapse detection of the colorectal cancer relapse in comparison with conventional control (including carcinoembryonic [CEA] levels and other classic radiological exams).
- Conditions
- Colorectal Cancer
- Being tested
- PET
- Keywords
- colorectal cancer stage II and III
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to colorectal cancer relapse
Secondary outcomes (3)
Evaluation of overall survival in the two groups
Measured: after curative resection of colorectal cancer stage II or III
Evaluation of the rate of curative surgery
Measured: after relapse
Comparison of the medical cost in the two detection strategies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionNov 2012
- Study completionApr 2013
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 University Hospital, LimogesThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole TUBIANA-MATHIEU, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199654
- Sponsor's protocol ID
- I03001
- Status last verified
- Apr 2013
- First submitted
- 14 Sep 2005
- Last updated
- 9 Apr 2013
- Results posted
- No
Publications
Monteil J, Le Brun-Ly V, Cachin F, Zasadny X, Seitz JF, Mundler O, Selvy M, Smith D, Rullier E, Lavau-Denes S, Lades G, Labrunie A, Lecaille C, Valli N, Leobon S, Terrebonne E, Deluche E, Tubiana-Mathieu N. Comparison of 18FDG-PET/CT and conventional follow-up methods in colorectal cancer: A randomised prospective study. Dig Liver Dis. 2021 Feb;53(2):231-237. doi: 10.1016/j.dld.2020.10.012. Epub 2020 Nov 2.
PubMed 33153929
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study
- ClinicalTrials.gov ID
- NCT00199654
- Acronym / sponsor ID
- I03001
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer stage II and III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Sep 2005 (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.
The follow up of colorectal cancer after curative surgery has to find loco-regional relapses or synchronous metastases, and to detect adenomas and new cancer on the rest of the colon.
The increase of survival after relapse of the colorectal cancer depends on the possibility of curative action or after chemotherapy response.
This is a Phase III open-labeled, multicenter, multidisciplinary, randomised study, comparing 2 arms of 188 patients (i.e. 376 total patients).
Study Period (date of first inclusion/last inclusion): 3 years.
Follow Up: 3 years.
The primary objective is the evaluation of PET performance in the earlier relapse detection of the colorectal cancer relapse in comparison with conventional control (including carcinoembryonic [CEA] levels and other classic radiological exams).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed and dated written informed consent
- Confirmed stage II or III (TNM)
- Patient with curative surgery for colorectal adenocarcinoma
- Total digestive endoscopy prior or post surgery.
- Age > 18 years old
Key exclusion criteria (7 listed)
- Serious concomitant pathology
- Uncontrolled diabetes with a classical treatment (glycaemia >1.4 g/l)
- Other malignant tumour within the last 5 years (except for curatively treated basocellular carcinoma of the skin or in situ cervical carcinoma).
- Uncontrolled infection
- Women who are pregnant or lactating
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 |
|---|---|---|
| PET | Procedure or surgery | – |
Primary outcome
Time to colorectal cancer relapse
3 secondary outcomes
Evaluation of overall survival in the two groups
Time frame: after curative resection of colorectal cancer stage II or III
Evaluation of the rate of curative surgery
Time frame: after relapse
Comparison of the medical cost in the two detection strategies
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 2013.
- Derived from this study: PubMed 33153929Monteil J, Le Brun-Ly V, Cachin F, Zasadny X, Seitz JF, Mundler O, Selvy M, Smith D, Rullier E, Lavau-Denes S, Lades G, Labrunie A, Lecaille C, Valli N, Leobon S, Terrebonne E, Deluche E, Tubiana-Mathieu N. Comparison of 18FDG-PET/CT and conventional follow-up methods in colorectal cancer: A randomised prospective study. Dig Liver Dis. 2021 Feb;53(2):231-237. doi: 10.1016/j.dld.2020.10.012. Epub 2020 Nov 2.
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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.
Nicole TUBIANA-MATHIEU, MD principal investigator
University Hospital, Limoges
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET in people with Colorectal Cancer, run by University Hospital, Limoges at 5 sites in France.
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 7 inclusion and 7 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 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to colorectal cancer relapse. 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 NCT00199654, 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 2013.