Colorectal CancerITEPNCT00624260
Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study
A study testing semi-annual systematic PET-TDM and PET-TDM for current indication in people with Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the three years following the tumoral resection with curative aim. Therefore, a prolonged follow-up and an intense monitoring are recommended to detect these recurrences precociously. 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?
- semi-annual systematic PET-TDM and PET-TDM for current indication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Jun 2015
- 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 a removed colorectal adenocarcinoma since less than 6 months, in total remission and for whom a monitoring is necessary to detect recurrences precociously.
- Patients with a removed colorectal tumour which is histologically proved and classified N+ and/or M+ (stage III or IV). Hepatic and/or pulmonary metastasis would have been totally removed since less 6 months before inclusion.
- Patients with a T4N0M0 tumour and operated in emergency (because of a tumoral perforation) can be included. (suppressed by amendment 1)
- 2 before criteria have been replaced by : Patients with colorectal adenocarcinoma which is histologically proved and classified stage II perforated, III or IV, totally removed, in total remission,
- if no metastatic, removed surgery must have been done since less 6 months;
- if metastatic, all metastasis would have been removed, the last surgery dating less 6 months.(amendment 1)
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- Casual extension check-up would have been realized before initial surgery or during a period of 6 months after surgery performed in emergency.
- informed consent signed
- Age ≥ 18 years
- Patient in ability to undergone hepatic or pulmonary resection in case of recurrence during the follow-up (ECOG ≤ 2)
- Willingness to control visits
Who cannot join
- pregnant or breast feeding women, or with a reproductive potential and no practicing an effective method of contraception during the second part of ovarian cycle ( PET is realised during the first part of ovarian cycle)
- Cancer stage I or II (except T4 operated in emergency) or IV without possibility to remove metastasis or R2 after surgery.
- Performance status contraindicating a hepatic or pulmonary surgery in case of recurrence.
- Patients likely to undergone chemotherapy, surgery or radiotherapy during 2 weeks before PET-TDM.
- Other progressive tumoral affection known, or colorectal cancer in progression.
- (Bad compliance to the study procedure.)(suppressed by amendment 1)
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- Not balanced diabetes. (added by amendment 1)
- Patients included in others clinical trials of imagery.
- Inability to provide informed consent signed.
- No social assurance.
Trial locations and contacts
1 site in 1 country.
About this study
The risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the three years following the tumoral resection with curative aim. Therefore, a prolonged follow-up and an intense monitoring are recommended to detect these recurrences precociously. Nevertheless, current consensual morphological and biological examinations are not very contributory, of difficult interpretation and expensive. The metabolic imagery in tomoscintigraphy by emission of positron coupled with the scanner, called PET-TDM, allows to identify more specifically recurrences, analyzes the whole body, detects hepatic metastasis more precociously and give some benefice for early diagnosis of lymph nodes recurrence. The principle purpose of this study is to evaluate if the systematic follow-up per PET-TDM allows detecting more often recurrences accessible to a curative surgery. We make the hypothesis that the systematic practice of PET- tomodensitometry (TDM) during the follow-up of CRC allows to decrease non curative recurrences appearance during the 3 years follow-up after a curative surgery.
Read the detailed description
Patients will be randomized in two groups: one (PET-TDM group) including a semi-annual systematic PET-TDM during usual follow-up (M6, M12, M18, M24, M30 and M36 after initial surgery) and the second (control group) in which one PET-TDM will be realized only for current indication (high isolated markers or before a metastasis curative resection) during usual follow-up. Will be included patients with a high risk of recurrence of a colorectal tumor N+ or M+ completely removed (R0 or R1) or tumor stage 4, no regional lymph node metastasis, no distant metastasis (T4N0M0) operated in emergency (tumoral perforation).
Patients will be followed-up during 3 years since the date of initial surgery. Conventional follow-up will be performed by consensual recommendations for all the patients. In the case of detecting a recurrence, the adapted treatment (surgery or chemotherapy or both) with curative aim will be implemented and the follow-up will be carried out in its term or death. In the case of non curable recurrence, the follow-up will be carried out in its term or death, and the PET-TDM will not be realised any more.
- Conditions
- Colorectal Cancer
- Being tested
- semi-annual systematic PET-TDM, PET-TDM for current indication
- Keywords
- Colorectal cancer, Recurrence, Positron Emission Tomography, Colorectal Cancer with high risk of recurrence stage III, Colorectal Cancer with high risk of recurrence stage IV, T4N0M0 operated in emergency( because of perforation)
- Medical subject headings
- Colorectal Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-annual systematic PET-TDMOther
semi-annual systematic PET-TDM
PET-TDM for current indicationOther
PET-TDM for current indication (high isolated markers or before a metastasis curative resection)
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Usual follow up : Pet-TDM for current indication (high isolated markers or before a metastasis curative resection) Receives: Other: PET-TDM for current indication |
| 1 | Experimental | Semi-annual systematic PET-TDM (M6, M12, M18, M24, M30 and M36 after initial surgery) Receives: Other: semi-annual systematic PET-TDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a non removable recurrence
Measured: at the end of the study
Secondary outcomes (3)
Survival without non removable tumor
Measured: At the end of the study
Overall survival
Measured: At the end of the study
Cost of the strategy
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2015
- Study completionJun 2015
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 Assistance Publique - Hôpitaux de ParisThe 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iradj Sobhani, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624260
- Sponsor's protocol ID
- P070142
- Acronym
- ITEP
- Status last verified
- Mar 2016
- First submitted
- 15 Feb 2008
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sobhani I, Itti E, Luciani A, Baumgaertner I, Layese R, Andre T, Ducreux M, Gornet JM, Goujon G, Aparicio T, Taieb J, Bachet JB, Hemery F, Retbi A, Mons M, Flicoteaux R, Rhein B, Baron S, Cherrak I, Rufat P, Le Corvoisier P, de'Angelis N, Natella PA, Maoulida H, Tournigand C, Durand Zaleski I, Bastuji-Garin S. Colorectal cancer (CRC) monitoring by 6-monthly 18FDG-PET/CT: an open-label multicentre randomised trial. Ann Oncol. 2018 Apr 1;29(4):931-937. doi: 10.1093/annonc/mdy031.
PubMed 29365058
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study
- ClinicalTrials.gov ID
- NCT00624260
- Acronym / sponsor ID
- ITEP / P070142
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Recurrence, Positron Emission Tomography, Colorectal Cancer with high risk of recurrence stage III, Colorectal Cancer with high risk of recurrence stage IV, T4N0M0 operated in emergency( because of perforation)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Feb 2008 (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 risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the three years following the tumoral resection with curative aim. Therefore, a prolonged follow-up and an intense monitoring are recommended to detect these recurrences precociously. Nevertheless, current consensual morphological and biological examinations are not very contributory, of difficult interpretation and expensive. The metabolic imagery in tomoscintigraphy by emission of positron coupled with the scanner, called PET-TDM, allows to identify more specifically recurrences, analyzes the whole body, detects hepatic metastasis more precociously and give some benefice for early diagnosis of lymph nodes recurrence. The principle purpose of this study is to evaluate if the systematic follow-up per PET-TDM allows detecting more often recurrences accessible to a curative surgery. We make the hypothesis that the systematic practice of PET- tomodensitometry (TDM) during the follow-up of CRC allows to decrease non curative recurrences appearance during the 3 years follow-up after a curative surgery.
Detailed description
Patients will be randomized in two groups: one (PET-TDM group) including a semi-annual systematic PET-TDM during usual follow-up (M6, M12, M18, M24, M30 and M36 after initial surgery) and the second (control group) in which one PET-TDM will be realized only for current indication (high isolated markers or before a metastasis curative resection) during usual follow-up. Will be included patients with a high risk of recurrence of a colorectal tumor N+ or M+ completely removed (R0 or R1) or tumor stage 4, no regional lymph node metastasis, no distant metastasis (T4N0M0) operated in emergency (tumoral perforation).
Patients will be followed-up during 3 years since the date of initial surgery. Conventional follow-up will be performed by consensual recommendations for all the patients. In the case of detecting a recurrence, the adapted treatment (surgery or chemotherapy or both) with curative aim will be implemented and the follow-up will be carried out in its term or death. In the case of non curable recurrence, the follow-up will be carried out in its term or death, and the PET-TDM will not be realised any more.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Other: PET-TDM for current indicationUsual follow up : Pet-TDM for current indication (high isolated markers or before a metastasis curative resection) |
| 1 | Experimental | Other: semi-annual systematic PET-TDMSemi-annual systematic PET-TDM (M6, M12, M18, M24, M30 and M36 after initial surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with a removed colorectal adenocarcinoma since less than 6 months, in total remission and for whom a monitoring is necessary to detect recurrences precociously.
- Patients with a removed colorectal tumour which is histologically proved and classified N+ and/or M+ (stage III or IV). Hepatic and/or pulmonary metastasis would have been totally removed since less 6 months before inclusion.
- Patients with a T4N0M0 tumour and operated in emergency (because of a tumoral perforation) can be included. (suppressed by amendment 1)
- 2 before criteria have been replaced by : Patients with colorectal adenocarcinoma which is histologically proved and classified stage II perforated, III or IV, totally removed, in total remission,
- if no metastatic, removed surgery must have been done since less 6 months;
Key exclusion criteria (10 listed)
- pregnant or breast feeding women, or with a reproductive potential and no practicing an effective method of contraception during the second part of ovarian cycle ( PET is realised during the first part of ovarian cycle)
- Cancer stage I or II (except T4 operated in emergency) or IV without possibility to remove metastasis or R2 after surgery.
- Performance status contraindicating a hepatic or pulmonary surgery in case of recurrence.
- Patients likely to undergone chemotherapy, surgery or radiotherapy during 2 weeks before PET-TDM.
- Other progressive tumoral affection known, or colorectal cancer in progression.
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 |
|---|---|---|
| semi-annual systematic PET-TDMsemi-annual systematic PET-TDM | Other | 1 |
| PET-TDM for current indicationPET-TDM for current indication (high isolated markers or before a metastasis curative resection) | Other | 2 |
Primary outcome
Percentage of patients with a non removable recurrence
Time frame: at the end of the study
3 secondary outcomes
Survival without non removable tumor
Time frame: At the end of the study
Overall survival
Time frame: At the end of the study
Cost of the strategy
Time frame: At the end of the study
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 18 Mar 2016.
- Derived from this study: PubMed 29365058Sobhani I, Itti E, Luciani A, Baumgaertner I, Layese R, Andre T, Ducreux M, Gornet JM, Goujon G, Aparicio T, Taieb J, Bachet JB, Hemery F, Retbi A, Mons M, Flicoteaux R, Rhein B, Baron S, Cherrak I, Rufat P, Le Corvoisier P, de'Angelis N, Natella PA, Maoulida H, Tournigand C, Durand Zaleski I, Bastuji-Garin S. Colorectal cancer (CRC) monitoring by 6-monthly 18FDG-PET/CT: an open-label multicentre randomised trial. Ann Oncol. 2018 Apr 1;29(4):931-937. doi: 10.1093/annonc/mdy031.
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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.
Iradj Sobhani, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semi-annual systematic PET-TDM and PET-TDM for current indication in people with Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 11 inclusion and 10 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 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Percentage of patients with a non removable recurrence (time frame: at the end of the study). 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 NCT00624260, 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 18 Mar 2016.