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

NCT ID: NCT00741481

Last Updated: 2011-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2010-07-31

Brief Summary

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.

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.

Conditions

Colorectal Cancer Metastatic; Early Response Evaluation; Fdg-PET

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

1

all study population

FDG-PET imaging

Intervention Type: PROCEDURE

FDG-PET imaging at D0 and D14 of first course of a new chemotherapy for advanced colorectal cancer

Interventions

FDG-PET imaging

FDG-PET imaging at D0 and D14 of first course of a new chemotherapy for advanced colorectal cancer

Intervention Type: PROCEDURE

Other Intervention Names

PET-CT SCan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Institut Jules Bordet, Service de Medecine

Principal Investigators

Alain - Hendlisz, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Jules Bordet, Université Libre de Bruxelles, Brussels

Locations

Institut Jules Bordet, Université Libre de Bruxelles

Brussels, , Belgium

Countries

Belgium

Other Identifiers

comité éthique IJB n° 1377

Identifier Type: -

Identifier Source: secondary_id

earlyPETmCRC

Identifier Type: -

Identifier Source: org_study_id