Resected Liver Metastases From Colorectal Cancer Clinical Trial
Official title:
Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Controlled Phase II/III Trial in China
This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.
| Status | Not yet recruiting |
| Enrollment | 432 |
| Est. completion date | September 2021 |
| Est. primary completion date | September 2020 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Diagnosis Criteria: All patients should have histologically confirmed colorectal adenocarcinoma with hepatic metastases and primary tumours completely resected during the operation and with colorectal metastatic to the liver confirmed pathologically after the operation as well as with negative surgical margin. Main criteria for inclusion: - Aged 18-75 years - Diagnosed as colorectal adenocarcinoma which only spread to the liver and with no extra-hepatic metastases - Prior curative resection of primary tumours (R0 resection) or concurrent feasible curative resection of primary tumours and hepatic metastases (R0 resection is met) - Performance status ECOG 0-1 - No serious complication occurred during or after metastases resection and affected subsequent treatment. - Hematology: White blood count ? 4.0X10^9/L, Absolute neutrophil count ?1.5X10^9/L, Platelet count ? 100 X10^9/L, Hemoglobin ? 100g/L - Blood biochemistry: Total bilirubin ?2mg/dL , Direct bilirubin equal or less than 1.5 times upper limit of normal (ULN), Alanine aminotransferase (ALT) no greater than 2.5 times ULN, Aspartate aminotransferase (AST) no greater than 2.5 times ULN, Serum creatinine no greater than ULN, or glomerular filtration rate equal or greater than 60 mL/min/1.73m^2 - Not pregnant or nursing at present - Fertile patients must use effective contraception - Able to withstand major operative procedure - No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ - No prior hepatic artery infusion therapy with 5-FU or floxuridine - No prior systemic chemotherapy for metastatic disease - No other concurrent chemotherapy - Able to understand and sign off informed consent form |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Fudan University Shanghai Cancer Center China | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Ye Xu |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival | Overall survival will be measured from the date of randomization up to the date of death of any cause | 5-year | No |
| Primary | Liver Relapse-Free Survival Rate | Liver Relapse-Free Survival (LRFS) is defined as the interval from the date of randomization to the date of liver localized metastatic relapse (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first. | 3-year | No |
| Secondary | Disease free survival | DFS is defined as the time interval from the date of randomization to the time of the first relapse at any site, death from any cause, or last recorded follow-up visit. | 3-year | No |