PET Evaluation of Response After 1 Course of Chemotherapy as Predictor of Treatment Outcome. (earlyPETmCRC)

This study has been completed.
Information provided by:
Jules Bordet Institute Identifier:
First received: August 25, 2008
Last updated: February 23, 2011
Last verified: February 2011

Study hypothesis : early decrease in fdg-pet measured SUV max after 1 cycle of chemotherapy can accurately predict response of chemotherapy as assessed by conventional radiology after 3 cycles of chemotherapy.

FDG-PET imaging will be done at J0 and J14 of a new line of chemotherapy treatment in metastatic colorectal cancer.

SUV max will be recorded and delta SUVmax will be compared to the results of conventional radiological evaluation after 3 courses of chemotherapy. Results will also be compared to the time to disease progression.

Condition Intervention
Colorectal Cancer Metastatic
Early Response Evaluation
Procedure: FDG-PET imaging

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Prognostic and Predictive Value of PETSCAn in ColoRectal Cancer (CRC)

Resource links provided by NLM:

Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:
  • compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by time to disease progression [ Time Frame: Time to Disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by tumour response rate following RECIST criteria. [ Time Frame: response rate ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
all study population
Procedure: FDG-PET imaging
FDG-PET imaging at D0 and D14 of first course of a new chemotherapy for advanced colorectal cancer
Other Name: PET-CT SCan

Detailed Description:

statistical hypothesis : Sample size calculation for FDG-PET in metastatic patients.

In the paper of Cascini et al. [1], they have 18 patients with a TRG response (TRG = Tumor Regression Grade) and 15 patients with no response.

SUV mean was measured at baseline and at day 12 in all 33 patients. All 33 patients showed a reduction in SUV-mean from baseline to day 12. The median reduction in SUV-mean was 63% (mean 66%) in responding tumors and 22% (mean 22%) for non responding tumors. Using a cutoff level of 52% a perfect accuracy could be obtained, i.e. all responding tumors had a SUV-mean reduction higher than 52% and all non responding tumors had a SUV-mean reduction lower than 52%.

(Standard deviation of the SUV-mean reduction was 25.) All 33 patients showed also a reduction in SUV-max from baseline to day 12. The median reduction in SUV-max was 62% in responding tumors and 28% in non responding tumors. (No information about mean or standard deviation of SUV-max available in [1].) Based on the data of SUV-mean we can do a power calculation based on the Wilcoxon test: In order to demonstrate an absolute difference in the mean of ΔSUV-mean of 44% between responding and non responding patients, with an estimated standard deviation of 25, using 35 patients (50% response, 50% no response), at a significance level of 5%, we obtain a power of 0.98.

For SUV-max, if we assume that the difference in the means is similar to the difference in the medians, i.e. 34% and the standard deviation is similar to the one of SUV-mean, i.e. 25, we obtain a power of 0.93 If we, to be safe, are a little bit less optimistic and estimate that the difference in the mean of ΔSUV-max between responding and non responding tumors would be a little lower than in [1]: 35%, and the standard deviation a little bit higher: 30, then we need 40 patients at a power of 0.90

Référence 1 : Cascini GL, Avallone A, Delrio P, Guida C, Tatangelo F, Marone P et al.: F-18-FDG PET is an early predictor of pathologic tumor response to preoperative radiochemotherapy in locally advanced rectal cancer. Journal of Nuclear Medicine 2006, 47: 1241-1248.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients >18 yrs old advanced evaluable colorectal cancer beginning a new line of chemotherapy


Inclusion Criteria:

  • advanced colorectal cancer
  • evaluable disease
  • signed informed consent

Exclusion Criteria:

  • no other cancer
  • no other life-threatening condition
  • unwillingness or inability to sign informed consent
  • active cerebral metastasis
  Contacts and Locations
Please refer to this study by its identifier: NCT00741481

Institut Jules Bordet, Université Libre de Bruxelles
Brussels, Belgium, 1190
Sponsors and Collaborators
Jules Bordet Institute
Principal Investigator: Alain - Hendlisz, MD Institut Jules Bordet, Université Libre de Bruxelles, Brussels
  More Information

No publications provided

Responsible Party: Alain Hendlisz, MD, Head, Gastroenterology Unit, Institut Jules Bordet, Service de Medecine Identifier: NCT00741481     History of Changes
Other Study ID Numbers: earlyPETmCRC, comité éthique IJB n° 1377
Study First Received: August 25, 2008
Last Updated: February 23, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Jules Bordet Institute:
metastatic colorectal cancer
fdg pet
response evaluation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 17, 2014