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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00741481
Other study ID # earlyPETmCRC
Secondary ID comité éthique I
Status Completed
Phase N/A
First received August 25, 2008
Last updated February 23, 2011
Start date June 2006
Est. completion date July 2010

Study information

Verified date February 2011
Source Jules Bordet Institute
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective


Intervention

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

Locations

Country Name City State
Belgium Institut Jules Bordet, Université Libre de Bruxelles Brussels

Sponsors (1)

Lead Sponsor Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by time to disease progression Time to Disease progression No
Secondary compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by tumour response rate following RECIST criteria. response rate No
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