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The aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma.
For locally advanced rectal carcinoma,preoperative chemoradiotherapy(CRT) achieved similar overall survival and better local control compared with postoperative therapy,so it was considered to be one of the standard therapy of these patients.But,not every one will be cured,the possible reason is the difference gene expression and mutation status among patients.So,we performed this trial to study the relationship between genetic factors and response of preoperative CRT for locally advanced rectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preoperative concurrent chemoradiation | Experimental | Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoperative concurrent chemoradiation | Radiation | Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation. |
| Measure | Description | Time Frame |
|---|---|---|
| gene expression in different response groups | 6 months after radical surgery |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival, disease free survival and local-regional free survival | 3 years after pre-operative chemoradiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| toxicity | any G3/4 toxicities according to CTC 3.0 | during concurrent chemoradiation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Jin, MD | Contact | +86-13601365130 | jingjin1025@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Jin, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting | Beijing | 100021 | China |
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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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|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |