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| Name | Class |
|---|---|
| Zhejiang Cancer Hospital | OTHER |
| Cancer Hospital of Guizhou Province | OTHER |
| Shandong Cancer Hospital and Institute | OTHER |
| Hebei Medical University Fourth Hospital |
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The purpose of this study is:
Adjuvant 5-FU based concurrent chemoradiotherapy and chemotherapy is the standard care for locally advanced stage II-III rectal cancer, based on several randomized Phase III clinical trials. With this standard treatment, 5-year local failure rate and distant metastasis rate is 10% and around 35%, respectively. Capecitabine, an analog of 5-fluoruracil (5FU), was demonstrated to have similar treatment results compared to 5-FU, but have much lower toxicities. Oxaliplatin based chemotherapy, also showed a better disease-free survival rate compared with 5-FU based-regimen. So far, some Phase I/II studies have shown the safety and preliminary results of either concurrent chemotherapy of capecitabine or oxaliplatin and capecitabine. The long-term results in comparison of capecitabine concurrent chemoradiotherapy with oxaliplatin/capecitabine concurrent chemoradiotherapy need to be further analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adjuvant capecitabine | To compare different adjuvant concurrent chemoradiotherapy regimen (Oxaliplatin with capecitabine vs capecitabine) for patients with II/III rectal cancer | ||
| adjuvant oxaliplatin and capecitabine | To compare different adjuvant concurrent chemoradiotherapy regimen (Oxaliplatin with capecitabine vs capecitabine) for patients with II/III rectal cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | the day of surgery to the date of the event |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival rate | the day of surgery to the date of death or last follow-up | |
| cumulative incidence of local recurrence | the day of surgery to the date of local recurrence | |
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Inclusion Criteria:
Exclusion Criteria:
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Multicenter patients enrollment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Jin, M.D. | Contact | 861087788280 | jingjin1025@163.com | |
| Yexiong Li, M.D. | Contact | 861087788860 | yexiong12@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yexiong Li, M.D. | CAMS | Principal Investigator |
| Jing Jin, M.D.;Ph.D | CAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jing Jin | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9278661 | Background | Tveit KM, Guldvog I, Hagen S, Trondsen E, Harbitz T, Nygaard K, Nilsen JB, Wist E, Hannisdal E. Randomized controlled trial of postoperative radiotherapy and short-term time-scheduled 5-fluorouracil against surgery alone in the treatment of Dukes B and C rectal cancer. Norwegian Adjuvant Rectal Cancer Project Group. Br J Surg. 1997 Aug;84(8):1130-5. | |
| 10699069 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| OTHER |
| Peking University Third Hospital | OTHER |
| General Hospital of Chinese Armed Police Forces | OTHER |
| Beijing Hospital | OTHER_GOV |
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| cumulative incidence of distant metastasis |
| the day of surgery to the date of distant metastasis |
| compliance | during adjuvant radiotherapy and chemotherapy |
| safety | the day of randomization to the date of death or last follow-up |
| Jing Jin | Recruiting | Beijing | Beijing Municipality | 100021 | China |
|
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| 34846525 | Derived | Li N, Zhu Y, Liu LY, Feng YR, Wang WL, Wang J, Wang H, Li GF, Tang Y, Hu C, Liu WY, Ren H, Wang SL, Wang WH, Song YW, Liu YP, Fang H, Tang Y, Lu NN, Chen B, Qi SN, Liu XF, Li YX, Jin J. Postoperative Chemoradiotherapy With Capecitabine and Oxaliplatin vs Capecitabine for Stage II to III Rectal Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2136116. doi: 10.1001/jamanetworkopen.2021.36116. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |