Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer

Study Overview
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Brief Summary
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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. 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

Official Title
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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）

Conditions
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Incurable Colorectal Cancer, RAS-wild-type

Intervention / Treatment
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* Drug: Cetuximab
* Drug: irinotecan
* Drug: fluorouracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer Eastern Cooperative Oncology Group performance status ≤2 and life expectancy of >3 months were enrolled. All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) None was previous exposure to Cetuximab or irinotecan . 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) All RAS were wildtype. - Exclusion Criteria: Pregnant or breast-feeding women; Clinically significant cardiac disease; Lack of physical integrity of the upper gastrointestinal tract; History of other malignancy; Central nervous system metastases. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: maintenance therapy<br>Initially, all subjects received 8 cycles of Cetuximab (400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks)plus FOLFIRI (irinotecan 180 mg/m2 IV on day 1 , leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks) . After 8 cycles or severe toxicity, patients received maintenance therapy comprising Cetuximab (250mg/m2 every week or 500mg/m2 every 2 weeks) and either irinotecan( 180 mg/m2 IV every 2 weeks) or fluorouracil arm( leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks ). In cases of unacceptable toxicity, only the related medication was stopped | Drug: Cetuximab<br>* 400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks<br>Drug: irinotecan<br>* 180 mg/m2 IV every 2 weeks<br>Drug: fluorouracil<br>* 400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks<br>* Other names: 5FU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | defined as the time from enrollment to death | 18 Months after the last subject participate in | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incurable colorectal cancer, maintenance therapy, Cetuximab