NCT00199654

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P50-P75 for phase_3 colorectal-cancer

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_3 colorectal-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

8.8 years

First QC Date

September 14, 2005

Last Update Submit

April 8, 2013

Conditions

Colorectal Cancer

Keywords

colorectal cancer stage II and III

Outcome Measures

Primary Outcomes (1)

  • Time to colorectal cancer relapse

Secondary Outcomes (3)

  • Evaluation of overall survival in the two groups

    after curative resection of colorectal cancer stage II or III

  • Evaluation of the rate of curative surgery

    after relapse

  • Comparison of the medical cost in the two detection strategies

Interventions

PETPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cancérologie et Hépato-Gastro-Entérologie

Bordeaux, 33000, France

Location

Institut François Baclesse

Caen, 14000, France

Location

Médecine Nucléaire

Limoges, 87000, France

Location

Oncologie Médicale

Limoges, 87000, France

Location

Oncologie Digestive

Marseille, 13000, France

Location

Related Publications (1)

  • 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.

    PMID: 33153929DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Nicole TUBIANA-MATHIEU, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 20, 2005

Study Start

February 1, 2004

Primary Completion

November 1, 2012

Study Completion

April 1, 2013

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

FR(5)