Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C) (RegARd-C)
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|ClinicalTrials.gov Identifier: NCT01929616|
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Chemorefractory Colorectal Adenocarcinoma||Drug: regorafenib||Phase 2|
The primary objective is to identify in a population of patients bearing advanced, refractory colorectal cancers, those who draw no benefit from treatment with regorafenib. There is no specific hypothesis underlying sample size and the study is therefore to be seen as exploratory.
- To analyze PFS and response rate (RR) in relationship with the same covariates as for OS
- To assess regorafenib efficacy (OS, PFS, RR) and safety profile in this study population.
- To assess the Disease control rate (DCR = Complete response [CR] + partial response [PR] + stable disease [SD])
- To compare the relative benefit (OS, PFS) of regorafenib according to history of treatment with bevacizumab.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Regorafenib Assessment in Refractory Advanced Colorectal Cancer|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||May 13, 2016|
|Actual Study Completion Date :||June 17, 2019|
A treatment cycle is defined as a 4 weeks period. Regorafenib will be administered once a day orally at a dose of 160 mg (4 tablets of 40 mg), for 3 weeks.
Patients will receive 160 mg regorafenib 1/day 3 weeks out of 4.
Other Name: stivarga (registred name)
- Overall survival (OS) [ Time Frame: 2 years from first patient in ]
- Occurence of Adverse events [ Time Frame: Every 28 days till 28 days after stopping therapy. An average of 2 months is expected. ]Assessment of safety will follow the WHO guidelines and classified according to NCI-CTCAE v. 4.0 and will be performed every 28 days until 28 days (safety follow up visit) after stopping therapy. Reasons for stopping therapy may include progression of disease or unbearable toxicities, or patient's decision.
- Evaluation of tumour response [ Time Frame: Every 2 months till progression of the disease. An average of 2 months is expected. ]RECIST 1.1-based radiological assessment (CT or MRI) will be made every 2 cycles, starting at day 28 of the second cycle till demonstration of progressive disease. An average of 2 months is expected.
- Metabolic response assessed by FDG PET [ Time Frame: 2 FDGPET will be perfomed : at Baseline (day 0) and at D14 ]FDGPET will be done twice during the study course : at baseline (at day 0, before treatment begin) and after 2 weeks.
- Molecular aberrations [ Time Frame: at day 0 (before treatment begins) and at D14, then repeated every 2 months until progression. An average of 2 months is expected. ]Genetic, epigenetic and molecular aberrations will be investigated using gene expression profiling, RNA and exome sequencing, and methylation profiling on the tumor biopsies and repeated blood samples collected during the trial. The relationship between the molecular aberrations,the patient's outcome (PFS, OS) and with metabolic response after treatment with regorafenib will be studied.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929616
|Study Chair:||Alain Hendlisz, MD||Jules Bordet Institute|