This phase II trial is assessing how 64Cu-ATSM (64Cu-copper(II) diacetylbis(N4-methylthiosemicarbazone)) PET/CT scan could predict neo adjuvant treatment response in rectum cancer locally advanced
The purpose of this study is to evaluate early and late tumor uptake of 64Cu-ATSM in predicting histological response to neo-adjuvant chemo-radiotherapy treatment in patients with locally advanced rectal cancer. Patients receive pre-therapeutic CT scan, Pelvic MRI and 18FDG (fluorodeoxyglucose) PET/CT (positron emission tomography) scan within 45 days before enrollment. 64Cu-ATSM PET/CT scan is done before chemoradiotherapy treatment start. About 3 MBq/Kg of 64Cu-ATSM are injected intravenously, two acquisition sequences are performed 1 hour and 23 to 25 hours after injection in order to evaluate early and late tumor uptake of 64Cu-ATSM. Patients are treated for 5 weeks by Capecitabine chemotherapy (1600 mg/m2/day) combined to 50 Gy radiotherapy. Pelvic MRI is performed 4 weeks after chemotherapy in order to evaluate the treatment efficacy. Surgery is scheduled 6 to 8 weeks after chemoradiotherapy. Tissue samples from previously collected rectal biopsy (obtained for diagnosis) and from surgery are used for assessing oxidative stress markers by Immuno-histochemical analysis. Chest, abdomen and pelvis CT scan is performed every 6 months after surgery in order to assess progression free survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
70
64 Cu-ATSM PET/CT scan
Institut de Cancerologie de l'Ouest (ICO)
Angers, France
CHU de BREST
Brest, France
Centre Eugene Marquis
Rennes, France
Centre Henri Becquerel
Rouen, France
Institut de cancerologie de l'Ouest
Relationship between early tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment
Early tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement, histological response Will be assessed by Rodel grading (Tumor Regression Grading)
Time frame: 4 months
Relationship between late tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment
Late tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement, histological response Will be assessed by Rodel grading (Tumor Regression Grading)
Time frame: 4 months
Correlation between 64Cu-ATSM uptake and oxidative stress markers
Aggressive zones corresponding to high redox potential areas will be assessed by Immuno-histochemical analysis on the surgical sample and on the pre-therapeutic biopsy
Time frame: 4 months
Progression free survival
Progression Free survival is the delay between surgery and the date of documented disease progression
Time frame: 2 years
18FDG-PET/CT and 64Cu-PET/CT uptakes
Correlation between 18FDG-PET/CT and 64Cu-PET/CT uptakes
Time frame: 45 days
Comparison between early and late 64Cu-ATSM uptakes in 64Cu-ATSM PET/CT images
Early and Late tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement
Time frame: 45 days
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Saint-Herblain, France
64Cu-ATSM toxicity
64Cu-ATSM toxicity will be assessed by vital signs monitoring within 2 hours after 64Cu-ATSM injection
Time frame: 45 days