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

This study has been completed.
Sponsor:
Information provided by:
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT00741481
First received: August 25, 2008
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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
Fdg-PET
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
1
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741481

Locations
Belgium
Institut Jules Bordet, Université Libre de Bruxelles
Brussels, Belgium, 1190
Sponsors and Collaborators
Jules Bordet Institute
Investigators
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
ClinicalTrials.gov 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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014