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Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study (ITEP)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
semi-annual systematic PET-TDM
PET-TDM for current indication
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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  • 2 before criteria have been replaced by : Patients with colorectal adenocarcinoma which is histologically proved and classified stage II perforated, III or IV, totally removed, in total remission,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)
  • 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

Exclusion Criteria:

  • 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)

  • Not balanced diabetes. (added by amendment 1)
  • Patients included in others clinical trials of imagery.
  • Inability to provide informed consent signed.
  • No social assurance.

Sites / Locations

  • CHU Henri Mondor

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm Description

Usual follow up : Pet-TDM for current indication (high isolated markers or before a metastasis curative resection)

Semi-annual systematic PET-TDM (M6, M12, M18, M24, M30 and M36 after initial surgery)

Outcomes

Primary Outcome Measures

Percentage of patients with a non removable recurrence

Secondary Outcome Measures

Survival without non removable tumor
Overall survival
Cost of the strategy

Full Information

First Posted
February 15, 2008
Last Updated
March 17, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00624260
Brief Title
Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study
Acronym
ITEP
Official Title
Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual follow up : Pet-TDM for current indication (high isolated markers or before a metastasis curative resection)
Arm Title
1
Arm Type
Experimental
Arm Description
Semi-annual systematic PET-TDM (M6, M12, M18, M24, M30 and M36 after initial surgery)
Intervention Type
Other
Intervention Name(s)
semi-annual systematic PET-TDM
Intervention Description
semi-annual systematic PET-TDM
Intervention Type
Other
Intervention Name(s)
PET-TDM for current indication
Intervention Description
PET-TDM for current indication (high isolated markers or before a metastasis curative resection)
Primary Outcome Measure Information:
Title
Percentage of patients with a non removable recurrence
Time Frame
at the end of the study
Secondary Outcome Measure Information:
Title
Survival without non removable tumor
Time Frame
At the end of the study
Title
Overall survival
Time Frame
At the end of the study
Title
Cost of the strategy
Time Frame
At the end of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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 Exclusion Criteria: 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) Not balanced diabetes. (added by amendment 1) Patients included in others clinical trials of imagery. Inability to provide informed consent signed. No social assurance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iradj Sobhani, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29365058
Citation
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.
Results Reference
derived

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Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study

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