Colorectal Cancer, Neoplasm Metastasis Clinical Trial
Official title:
A Multi-center, Single-arm, Pilot Study of 5-FU Based Doublet Chemotherapy Plus Bevacizumab as Neoadjuvant Therapy for Patients With Previously Untreated Unresectable Liver-only Metastases From Colorectal Cancer
| Verified date | March 2016 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: State Food and Drug Administration (SFDA) |
| Study type | Interventional |
This open-label, single arm, multicenter study will evaluate the resection rate in patients with colorectal cancer and previously untreated unresectable liver-only metastases after adding Avastin (bevacizumab) to 5-FU based doublet chemotherapy in the neoadjuvant setting. Patients will receive standard 5-FU based chemotherapy plus Avastin 5 mg/kg every 2 weeks for a maximum of 12 cycles combined pre- and postoperatively unless they experience progressive disease or unacceptable toxicity.
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Adult Chinese patients, 18-75 years of age - Histologically confirmed adenocarcinoma in colon or rectum with primary lesion surgically removed - Previously untreated unresectable liver-only metastases - Liver lesions determined to be unresectable by multidisciplinary team (MDT, consisting of experienced hepatic surgeons, medical oncologist and radiologist). Guidelines used to determine unresectability includes: - R0 treatment infeasible with resection - cannot spare two adjacent liver segments - retention of liver volume <30% - vascular flow and biliary drainage cannot be preserved - No previous treatment against liver metastases, including chemotherapy, surgery, radiotherapy, TACE and target therapy - Adequate hematological, renal and hepatic function - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Life expectancy > 3 months Exclusion Criteria: - The relapse has occurred within 6 months of completion of the adjuvant treatment - Expected impossible to achieve R0 resection and/or gain 30% residual liver volume even with responsive neoadjuvant therapy - Patient cannot tolerate the surgery - Other malignancies in the past 5 years, except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix - Any extrahepatic metastases and/or recurrence of the primary tumor - Any residual toxicity from previous chemotherapy (except alopecia) of NCI CTC v.4.0 grade 2 - Hypertension crisis or encephalopathy - Pregnant or lactating women - Clinically significant cardiovascular disease - Evidence of bleeding diathesis or coagulopathy - Current or recent (within 10 days of study drug initiation) use of full dose of aspirin, clopidrogel or warfarin - History or evidence of CNS disease (e-g- primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complete resection rate (R0) in metastatic colorectal cancer patients with previously unresectable liver-only metastases | approximately 3 years | No | |
| Secondary | Objective response rate (ORR), tumor assessments according to RECIST v.1.1 criteria | approximately 3 years | No | |
| Secondary | Progression-free survival (PFS) for all patients enrolled in the study | approximately 3 years | No | |
| Secondary | Disease-free survival (DFS) for patients who achieve complete resection | approximately 3 years | No | |
| Secondary | Safety: Incidence of adverse events | approximately 3 years | No |