Incurable Colorectal Cancer Clinical Trial
Official title:
Efficacy and Tolerance of Cetuximab Combined With Irinotecan or Fluorouracil as Maintenance Therapy in Patients With RAS-wild-type Incurable Advanced Colorectal Cancer （Confirm Study）
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
| Status | Recruiting |
| Enrollment | 54 |
| Est. completion date | July 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. - |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Tianshu Liu |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The progression free-survival | 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 | 8 Months after the last subject participate in | No |
| Secondary | Overall survival | defined as the time from enrollment to death | 18 Months after the last subject participate in | No |
| Secondary | Grade 3 and 4 adverse Events as a Measure of Safety and Tolerability | Toxicity was graded according to the criteria of the National Cancer Institute Common Terminology for Adverse Events (version 4.0). | 3 Months after the last subject end the treatment | Yes |