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PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Time to colorectal cancer relapse

Safety Issue:

No

Principal Investigator

Nicole TUBIANA-MATHIEU, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Limoges

Authority:

France: Direction Générale de la Santé

Study ID:

I03001

NCT ID:

NCT00199654

Start Date:

February 2004

Completion Date:

April 2013

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer stage II and III
  • Colorectal Neoplasms

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