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The study evaluates the associations between peak and valley concentrations of SN-38 with the efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6 /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end point are toxicity and pCR rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT group | Experimental | Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood concentration check | Diagnostic Test | Blood concentration check:the plasma concentration of SN-38 was detected by HPLC (high-performance liquid chromatography) at 1.5 h and 49.0 h after CPT-11 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 | the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 | During the chemoradiation weekly,assessed up to 5 weeks |
| pathological response rate | pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen. | Surgery scheduled 6-8 weeks after the end of chemoradiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji Zhu, PhD | Contact | +86-2164175590 | 81607 | leo.zhu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhen Zhang, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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