The purpose of the study is to evaluate the performance of various tumor response criteria (Choi and RECIST1.1 criteria) in the assessment of regorafenib activity. Moreover, an assessment of the tumor heterogeneity will be made using computed tomographic texture analysis (CTTA)
This is a phase II study in patients with metastatic colorectal cancer treated by regorafenib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
160mg once daily during 3 weeks followed by 1 week off therapy. Regorafenib will be taken until disease progression according to the CHOI and RECIST1.1 criteria, death or inacceptable toxicity.
CHU Jean Minjoz
Besançon, France
Hôpitlal Henri Mondor
Créteil, France
Institut Hospitalier Franco-Britannique
Levallois-Perret, France
CHRU Claude Huriez
Lille, France
Tumor response rate at 2 months according Choi Criteria
Time frame: 2 months after the beginning of treatment
Tumor response rate at 1 and 2 months according to RECIST1.1
Time frame: At 1 month and 2 months after the beginning of treatment
Tumor response rate at 1 month according to Choi criteria
Time frame: At 1 month after the beginning of treatment
Best overall response rate (BOR) according to Choi criteria and to RECIST 1.1
Time frame: BOR is the best response recorded from the strat of treatment until treatment failure up to 36 months
Disease control rate (DCR)
Time frame: DCR is the proportion of patient with tumor response (CR or RP) or tumor stabilization as best response from the inclusion until treatment failure, up to 36 months
Overall Survival (OS)
Time frame: Assessed from the date of study drug start to the date of patient death, due to any cause or to the last date the patient was known to be alive, up to 36 months
Progression free survival (PFS)
Time frame: PFS is the time from the date of study drug start to the date of progressive disease or death due to any cause, up to 36 months
Specificity of Choi criteria at 1 month in identifying patients with long or short OS (using median OS as cut-off value).
Time frame: At 1 month after inclusion
Evaluation of tumor heterogeneity with TexRAD software
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ICM Val D'Aurelle
Montpellier, France
Hôpital Pitié Salpêtrière
Paris, France
Hôpital Saint Antoine
Paris, France
Insitut Mutualiste Montouris
Paris, France
Threshold of the CTTA parameters (Skewness, Kurtosis, Entropy, Uniformity) provided by the TexRAD software at baseline and optimal variations of these parameters on the CT performed at one month (compared to baseline).
Time frame: At baseline and 1 month after inclusion
Serious adverse events( SAE) and adverse event (AE)
assessed by NCI-CTCAE4.0
Time frame: Up to 36 months
Identify early prognostic biomarkers of regorafenib
Time frame: at baseline, Cycle 1 Day 15, cycle 2 Day 15 and end of treatment
Correlation between Baseline cell free DNA and survival outcomes (PFS and OS)
Time frame: at baseline, Cycle 1 Day 15, cycle 2 Day 15 and end of treatment