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This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maintenance therapy | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | 400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks |
| |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianshu Liu, Doctor | Contact | +861368 1973 996 | liu.tianshu@zs-hospital.sh.cn | |
| yiyi yu, Master | Contact | +86 1381 6730 912 | yu.yiyi@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tianshu Liu, Doctor | Medicine-Oncology Derpartment of Zhongshan hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| irinotecan |
| Drug |
180 mg/m2 IV every 2 weeks |
|
| fluorouracil | Drug | 400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks |
|
|
| 3 Months after the last subject end the treatment |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |