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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00199654
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):

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).


Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: PET Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study
Study Start Date : February 2004
Primary Completion Date : November 2012
Study Completion Date : April 2013

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Time to colorectal cancer relapse

Secondary Outcome Measures :
  1. Evaluation of overall survival in the two groups [ Time Frame: after curative resection of colorectal cancer stage II or III ]
  2. Evaluation of the rate of curative surgery [ Time Frame: after relapse ]
  3. Comparison of the medical cost in the two detection strategies

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199654


Locations
France
Cancérologie et Hépato-Gastro-Entérologie
Bordeaux, France, 33000
Institut François Baclesse
Caen, France, 14000
Médecine Nucléaire
Limoges, France, 87000
Oncologie Médicale
Limoges, France, 87000
Oncologie Digestive
Marseille, France, 13000
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Nicole TUBIANA-MATHIEU, MD University Hospital, Limoges
More Information

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00199654     History of Changes
Other Study ID Numbers: I03001
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 9, 2013
Last Verified: April 2013

Keywords provided by University Hospital, Limoges:
colorectal cancer stage II and III

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases