Incurable Colorectal Cancer, RAS-wild-type
Conditions
Keywords
Incurable colorectal cancer, maintenance therapy, Cetuximab
Brief summary
1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer. 2. The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months. This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy
Interventions
DRUGCetuximab
400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks
DRUGirinotecan
180 mg/m2 IV every 2 weeks
DRUGfluorouracil
400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks
Sponsors
Tianshu Liu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer 2. Eastern Cooperative Oncology Group performance status ≤2 and 3. life expectancy of \>3 months were enrolled. 4. All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) 5. None was previous exposure to Cetuximab or irinotecan . 6. Patients had to have adequate haematological (absolute neutrophil count \>1.5 × 109/l; platelet count \>100 × 109/l; haemoglobin \>9 g/dl), hepatic \[total bilirubin \<1.5 × the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase \<2.5 × ULN, or \<5 × ULN in the case of hepatic metastases or \<10 × ULN in the case of osseous metastases; alkaline phosphatase \<2.5 × ULN, or \<5 × ULN or \<10 × ULN in the case of hepatic or osseous metastases, respectively\] and renal function (creatinine clearance ≥60 ml/min) 7. All RAS were wildtype. -
Exclusion criteria
1. Pregnant or breast-feeding women; 2. Clinically significant cardiac disease; 3. Lack of physical integrity of the upper gastrointestinal tract; 4. History of other malignancy; 5. Central nervous system metastases. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The progression free-survival | 8 Months after the last subject participate in | defined as the time from enrollment to progression or death RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 18 Months after the last subject participate in | defined as the time from enrollment to death |
| Grade 3 and 4 adverse Events as a Measure of Safety and Tolerability | 3 Months after the last subject end the treatment | Toxicity was graded according to the criteria of the National Cancer Institute Common Terminology for Adverse Events (version 4.0). |
Countries
China
Contacts
Primary ContactTianshu Liu, Doctor
Backup Contactyiyi yu, Master
Outcome results
None listed