Study of Colorectal Cancer Patients (Stage IIIC) With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX
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|ClinicalTrials.gov Identifier: NCT02425683|
Recruitment Status : Terminated (insufficient accrual)
First Posted : April 24, 2015
Last Update Posted : February 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms Adenocarcinoma of the Colon Adenocarcinoma of the Rectum||Drug: Regorafenib||Phase 2|
Patients with Stage IIIC colon cancer have a 5-year survival rate of 28%. Stage III colon cancer indicates that lymph nodes are involved.
Adjuvant FOLFOX only reduces the risk of recurrence of colorectal cancer by 40%, so almost 50% of patients still die from the disease. It is estimated that 50% of the patients relapse within 18 months.
Because the prognosis of colorectal cancer is dependent on disease stage and because metastatic disease is incurable, the concept of adding regorafenib to adjuvant FOLFOX has been developed to allow patients with high-risk colorectal cancer the best chance of cure.
It is proposed to treat high-risk colorectal patients (Stage IIIC [T4a, N2a, M0] or [T3-4a,N2b, M0], or [T4b, N1-N2, M0] per American Joint Committee on Cancer [AJCC] 7th ed.) selected from the iKnowMed (iKM) electronic health records database who have completed adjuvant FOLFOX. This feasibility study is to find the starting dose of regorafenib and estimates that at least 75% of the patients will be able to tolerate the full dose of regorafenib after receiving adjuvant FOLFOX.
Patients will be randomly assigned to regorafenib or to SOC (no treatment). In order to test the best tolerated starting dose, the first 50 patients will receive regorafenib and will be randomized 1:1 to either 120 mg by mouth (PO) or 160 mg PO. If the 120 mg dose is well tolerated and the toxicities are not severe (Grade 2 or less) upon the completion of cycle 2, the dose will be increased to 160 mg starting with Cycle 3. Registration and randomization of patients will resume after the 26th then after the 50th patient completes 3 cycles of study treatment. The Data Safety Monitoring Board (DSMB) will meet after the 26th patient completes 3 cycles of treatment and the second meeting will take place after the 50th patient completes 3 cycles. If needed, a third DSMB meeting will be scheduled. The remaining 214 patients will be randomized 2:3 to the decided starting dose versus SOC.
In addition, evaluating the Texture (spatial variations in pixel intensity) in computed tomography (CT) scans might help predict the risk of recurrence. Therefore, CT disks will be sent to Imaging Endpoints Core Lab, Scottsdale, AZ, where the TexRAD platform (a software algorithm) will be used for analysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Phase II Study of High-Risk Colorectal Cancer Patients (Stage IIIC) Treated With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX|
|Actual Study Start Date :||March 26, 2015|
|Actual Primary Completion Date :||September 21, 2017|
|Actual Study Completion Date :||September 21, 2017|
Regorafenib 120 or 160 mg by mouth every day for the first 21 days of each 28-day cycle. If the dose is tolerated during the first 2 cycles in the 120 mg group, in Cycle 3 the 120 mg dose will be increased to 160 mg by mouth each day for the first 21 days of each 28-day cycle for 4 more cycles for a total of 6 cycles or 6 months of therapy.
120 mg or 160 mg by mouth each day for first 21 days of each 28-day cycle, for maximum of 6 cycles
No Intervention: Standard of Care (No Treatment)
No study drug (which is the standard care for Stage IIIC colorectal cancer patients after they've received FOLFOX chemotherapy).
- Starting Dose of Regorafenib [ Time Frame: 1 year ]To find the starting dose of regorafenib. The first 50 patients will be randomly assigned to receive regorafenib either 120 mg or 160 mg by mouth daily for 1st 21 days of each 28-day cycle for two cycles. Based on safety profile review of adverse events, a final starting dose will be selected for remaining patients assigned to regorafenib.
- Number of Patients Completing Full 6 Cycles [ Time Frame: 4.5 years ]To have at least 75% of enrolled Stage IIIC high-risk colorectal cancer patients in each treatment arm complete the full duration of adjuvant therapy.
- Overall survival [ Time Frame: 4.5 years ]To estimate overall survival (OS) in each treatment arm
- Number of Adverse Events (AEs) [ Time Frame: 4.5 years ]To estimate Adverse Events (AE) in each treatment arm.
- Disease-free survival (DFS) [ Time Frame: 4.5 years ]To determine the association between Texture results in CT scans and DFS in a retrospective subanalysis.
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): NCT02425683
|United States, Florida|
|Including Dallas, TX, Ocala, FL, Denver, CO, Florida, United States|
|Principal Investigator:||Thomas H. Cartwright, MD||US Oncology Research, McKesson Specialty Health|