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Prospectively Investigate the effectiveness and safety of neoadjuvant Bevacizumab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS mutant-type locally advanced rectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab+mFOLFOX6 | Drug | Bevacizumab 5mg/kg d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peri-operative complications | Complications occurring in the perioperative period | From the start of treatment to 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response rate | Tumor Regression Grade 0-1 | 2 weeks after surgery |
| Pathological complete response rate | Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0) |
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Inclusion Criteria:
A biopsy proven histological diagnosis of rectal adenocarcinoma;
An ARMS-PCR proven KRAS, NRAS mutation, excluding BRAF mutation or microsatellite instablility-High;
No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;
MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;
Age between 18-75 years;
ECOG (Eastern US Cooperative Oncology Group) score: 0-1;
Has sufficient organ function:
Willing to participate and informed consent signed;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenghao Cai, MD | Contact | +862164458887 | c3z2h1@alumni.sjtu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200020 | 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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| 2 weeks after surgery |
| 2-year local control rate | Refers to the probability of not finding local recurrence of tumor within 2 years,including anastomotic recurrence confirmed by pathological biopsy, pelvic tumor recurrence confirmed by imaging examination, or suspected pelvic recurrence with CEA exceeding the normal upper limit. | 2 years |
| 2-year metastasis-free rate | Refers to the probability of no distant metastasis within 2 years | 2 years |
| Overall survival | Refers to the time from the start of treatment to death due to any cause. | 2 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |