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To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT with Dendrobium huoshanense Suppository | Experimental | Dendrobium huoshanense Suppository: 1.7g rectal administration per day for 5 weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2 (UGT1A1*28 and *6 :6/7+GG or 6/6+GA) or 50mg/m2 (UGT1A1*28 and *6 :7/7+GG or 6/6+AA or 6/7+GA). |
|
| CRT with Placebo | No Intervention | Placebo: 1.7g rectal administration per day for 5 weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2 (UGT1A1*28 and *6 :6/7+GG or 6/6+GA) or 50mg/m2 (UGT1A1*28 and *6 :7/7+GG or 6/6+AA or 6/7+GA). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dendrobium Huoshanense Suppository | Drug | 1.7g rectal administration per day for 5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| ≥Grade 2 proctitis | During chemoradiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji Zhu, MD | Contact | 571-88128142 | +86 | leo.zhu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ji Zhu | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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