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Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional fraction | Active Comparator | Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily |
|
| SIB | Experimental | Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional fraction | Radiation | capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Pathological complete remission rate (pCR) | after pathological examination of surgical speciments (6-8 weeks after chemoradiation) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE) |
| Measure | Description | Time Frame |
|---|---|---|
| • Disease-free survival | Followup will be done every 3 months in first 2 years, and every 6 months after 2 years. | 3 year afte concurrent chemoradiation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Jin, Professor | Contact | 87788280 | jingjin1025@163.com | |
| Hua Ren, Attending | Contact | 87788122 | renhua2009@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Jin, proffessor | Dept of Radiation oncology, Cancer hospital, CAMS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, CAMS | 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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| SIB | Radiation | Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily |
|
| during preoperative treatment and after surgery for 5 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |