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Positron Emission Tomography (PET) Interest in the Follow Up of Colorectal Cancer Stage II and III

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
PET
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring colorectal cancer stage II and III

Eligibility Criteria

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

Inclusion Criteria: 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) Exclusion Criteria: 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.

Sites / Locations

  • Cancérologie et Hépato-Gastro-Entérologie
  • Institut François Baclesse
  • Médecine Nucléaire
  • Oncologie Médicale
  • Oncologie Digestive

Outcomes

Primary Outcome Measures

Time to colorectal cancer relapse

Secondary Outcome Measures

Evaluation of overall survival in the two groups
Evaluation of the rate of curative surgery
Comparison of the medical cost in the two detection strategies

Full Information

First Posted
September 14, 2005
Last Updated
April 8, 2013
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT00199654
Brief Title
Positron Emission Tomography (PET) Interest in the Follow Up of Colorectal Cancer Stage II and III
Official Title
PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer stage II and III

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
376 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
PET
Primary Outcome Measure Information:
Title
Time to colorectal cancer relapse
Secondary Outcome Measure Information:
Title
Evaluation of overall survival in the two groups
Time Frame
after curative resection of colorectal cancer stage II or III
Title
Evaluation of the rate of curative surgery
Time Frame
after relapse
Title
Comparison of the medical cost in the two detection strategies

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole TUBIANA-MATHIEU, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancérologie et Hépato-Gastro-Entérologie
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Institut François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Médecine Nucléaire
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Oncologie Médicale
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Oncologie Digestive
City
Marseille
ZIP/Postal Code
13000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33153929
Citation
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.
Results Reference
derived

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Positron Emission Tomography (PET) Interest in the Follow Up of Colorectal Cancer Stage II and III

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