Study of Colorectal Cancer Patients (Stage IIIC) With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX

Colorectal Neoplasms Clinical Trial

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

Status Terminated

Clinical Trial Summary

This study, for patients who have Stage IIIC colorectal cancer and who underwent 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) chemotherapy after surgery, will test to see if regorafenib given after the completion of FOLFOX improves treatment, compared to standard of care (SOC), which is no further treatment.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Colon
• Adenocarcinoma of the Rectum
• Colorectal Neoplasms

• NCT number: NCT02425683
• Study type: Interventional
• Source: US Oncology Research
• Status: Terminated
• Phase: Phase 2
• Start date: March 26, 2015
• Completion date: September 21, 2017