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Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study

18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study

Patients will be randomized in two groups: one (PET-TDM group) including a semi-annual
systematic PET-TDM during usual follow-up (M6, M12, M18, M24, M30 and M36 after initial
surgery) and the second (control group) in which one PET-TDM will be realized only for
current indication (high isolated markers or before a metastasis curative resection) during
usual follow-up. Will be included patients with a high risk of recurrence of a colorectal
tumor N+ or M+ completely removed (R0 or R1) or tumor stage 4, no regional lymph node
metastasis, no distant metastasis (T4N0M0) operated in emergency (tumoral perforation).

Patients will be followed-up during 3 years since the date of initial surgery. Conventional
follow-up will be performed by consensual recommendations for all the patients. In the case
of detecting a recurrence, the adapted treatment (surgery or chemotherapy or both) with
curative aim will be implemented and the follow-up will be carried out in its term or death.
In the case of non curable recurrence, the follow-up will be carried out in its term or
death, and the PET-TDM will not be realised any more.

Inclusion Criteria:

- Patients with a removed colorectal adenocarcinoma since less than 6 months, in total
remission and for whom a monitoring is necessary to detect recurrences precociously.

- Patients with a removed colorectal tumour which is histologically proved and
classified N+ and/or M+ (stage III or IV). Hepatic and/or pulmonary metastasis would
have been totally removed since less 6 months before inclusion.

- Patients with a T4N0M0 tumour and operated in emergency (because of a tumoral
perforation) can be included. (suppressed by amendment 1)

- 2 before criteria have been replaced by : Patients with colorectal adenocarcinoma
which is histologically proved and classified stage II perforated, III or IV, totally
removed, in total remission,

- if no metastatic, removed surgery must have been done since less 6 months;

- if metastatic, all metastasis would have been removed, the last surgery dating less 6
months.(amendment 1)

- Casual extension check-up would have been realized before initial surgery or during a
period of 6 months after surgery performed in emergency.

- informed consent signed

- Age ≥ 18 years

- Patient in ability to undergone hepatic or pulmonary resection in case of recurrence
during the follow-up (ECOG ≤ 2)

- Willingness to control visits

Exclusion Criteria:

- pregnant or breast feeding women, or with a reproductive potential and no practicing
an effective method of contraception during the second part of ovarian cycle ( PET is
realised during the first part of ovarian cycle)

- Cancer stage I or II (except T4 operated in emergency) or IV without possibility to
remove metastasis or R2 after surgery.

- Performance status contraindicating a hepatic or pulmonary surgery in case of

- Patients likely to undergone chemotherapy, surgery or radiotherapy during 2 weeks
before PET-TDM.

- Other progressive tumoral affection known, or colorectal cancer in progression.

• (Bad compliance to the study procedure.)(suppressed by amendment 1)

- Not balanced diabetes. (added by amendment 1)

- Patients included in others clinical trials of imagery.

- Inability to provide informed consent signed.

- No social assurance.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Percentage of patients with a non removable recurrence

Outcome Time Frame:

at the end of the study

Safety Issue:


Principal Investigator

Iradj Sobhani, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

June 2008

Completion Date:

January 2016

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • Recurrence
  • Positron Emission Tomography
  • Colorectal Cancer with high risk of recurrence stage III
  • Colorectal Cancer with high risk of recurrence stage IV
  • T4N0M0 operated in emergency( because of perforation)
  • Rectal Neoplasms
  • Colorectal Neoplasms