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Pathological complete response, (pCR) correlates with a favourable 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 IMRT combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preoperative chemoradiation | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemoradiation | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete remission rate (pCR) | A TME surgery will be done 6-8 weeks after concurrent chemoradiation, pathological examination of surgical speciments will be show Pathological complete remission rate (pCR) | after pathological examination of surgical speciments (6-8 weeks after chemoradiation) |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and late toxicity | 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 toxicites will be assessed every 6 months from the third year after surgery. | Toxicity/safety:during preoperative treatment, early and late postoperative follow up |
| 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:
Malignancy of the rectum other than adenocarcinoma
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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 |
|---|---|
| D059248 | Chemoradiotherapy |
| D000069287 | Capecitabine |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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|
|
| D003841 |
| Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |