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| Name | Class |
|---|---|
| The Third People's Hospital of Chengdu | OTHER |
| Chengdu Fifth People's Hospital | OTHER |
| Peking Union Medical College | OTHER |
| Peking University Cancer Hospital & Institute |
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To compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer.
Neoadjuvant Chemotherapy alone has showed much benefit for low/ intermediate risk stage II/III rectal cancer which would be verified by the PROSPECT trial. However, the effect of the Neoadjuvant chemotherapy was heterogeneous in different patients. It's important to verify those chemo-resistant cases as early as possible. So that, this trial will compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer to explore whether those chemotherapeutic non-responders after 2 cycles Capox was non-inferior to those after 4 cycles chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 cycles group | Experimental | patients which recruited have 2 cycles Capox regimen (oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals), then those patients with no sever chemotheraputic AE, have TME operation after reevaluation and randomization. |
|
| 4 cycles group | Other | patients which recruited have 2 cycles Capox regimen (oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals), then those patients with no sever chemotheraputic AE, have two more cycles chemotherapy and TME operation after reevaluation and randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capox chemotherapy | Drug | oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological Tumor Regression Grade evaluation | pTRG | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| rate of chemotherapeutic complication | 12 weeks | |
| 3-year overall survival | the cumulative overall survival rate of the patients(events defined as all caused death) | 3 year after recruiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genecast Biotechnology Co., Ltd | Wuxi | Jiangsu | 214104 | China | ||
| the Third People'S Hospital of Chengdu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37312165 | Derived | Shen Y, Shi W, Huang C, Gong X, Wei M, Meng W, Deng X, Wang Z; COPEC groups. Comparison of the pathological response to 2 or 4 cycles of neoadjuvant CAPOX in II/III rectal cancer patients with low/intermediate risks: study protocol for a prospective, non-inferior, randomized control trial (COPEC trial). Trials. 2023 Jun 13;24(1):397. doi: 10.1186/s13063-023-07405-x. |
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| OTHER |
| Sun Yat-Sen University Cancer Center | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Yunnan Cancer Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| The Affiliated Hospital Of Guizhou Medical University | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
| Nanchong Central Hospital | OTHER_GOV |
| Dazhou Central Hospital | OTHER |
| Leshan People's Hospital | UNKNOWN |
| GeneCast Biotechnology Co., Ltd. | INDUSTRY |
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| disease free survival | the cumulative disease free survival rate of the patients(events defined as tumor recurrence at any sites) | 3 year after recruiting |
| cumulative distant recurrence rate | cumulative recurrence rate of Rectal cancer after the radical surgery outside the pelvic cavity | 3 year after recruiting |
| cumulative local recurrence rate | cumulative recurrence rate of Rectal cancer after the radical surgery within the pelvic cavity or in the wounds | 3 year after recruiting |
| Chengdu |
| Sichuan |
| 610000 |
| China |
| West China Hospital | Chengdu | Sichuan | 610000 | China |
| The Third Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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