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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00199654
First received: September 14, 2005
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Colorectal Cancer
 Procedure: PET
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Time to colorectal cancer relapse [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of overall survival in the two groups [ Time Frame: after curative resection of colorectal cancer stage II or III ] [ Designated as safety issue: No ]
  • Evaluation of the rate of curative surgery [ Time Frame: after relapse ] [ Designated as safety issue: No ]
  • Comparison of the medical cost in the two detection strategies [ Designated as safety issue: No ]

Enrollment: 376
Study Start Date: February 2004
Study Completion Date: April 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199654

Locations
France
Cancérologie et Hépato-Gastro-Entérologie
Bordeaux, France, 33000
Institut François Baclesse
Caen, France, 14000
Oncologie Médicale
Limoges, France, 87000
Médecine Nucléaire
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

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00199654     History of Changes
Other Study ID Numbers: I03001
Study First Received: September 14, 2005
Last Updated: April 8, 2013
Health Authority: France: Direction Générale de la Santé

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

ClinicalTrials.gov processed this record on May 19, 2013