Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer
NCT ID: NCT02071069
Last Updated: 2015-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
54 participants
INTERVENTIONAL
2013-07-31
2016-07-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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maintenance therapy
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
Cetuximab
400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks
irinotecan
180 mg/m2 IV every 2 weeks
fluorouracil
400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks
Interventions
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Cetuximab
400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks
irinotecan
180 mg/m2 IV every 2 weeks
fluorouracil
400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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. -
18 Years
ALL
No
Sponsors
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Tianshu Liu
OTHER
Responsible Party
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Tianshu Liu
Director of Medicine-Oncology department
Principal Investigators
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Tianshu Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Medicine-Oncology Derpartment of Zhongshan hospital
Locations
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Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZS-ON-05
Identifier Type: -
Identifier Source: org_study_id