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This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery (TEM) or endoscopic local resection for early low rectal cancer(cT 1-3N0M0).Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life (QoL) will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant concurrent Chemoradiotherapy plus consolidation chemotherapy followed by TEM | Experimental | All the patients will receive neoadjuvant chemoradiotherapy ( CapOx + radiotherapy) for 2 cycles, one week after chemoradiotherapy, the first evaluation including MRI, colonoscopy, digital rectal examination and serum CEA will be conducted. Patients without tumor progression will continue 4 cycles of chemotherapy (CapOx) until next imaging and serum assessment. After the second assessment, for patients with tumor regression and suitable for TEM will receive local resection otherwise TME. Following treatment strategy will be made base on the final pathology evaluation after surgery, patients with good pathological response (ypT 0-1 without neural vascular invasion) will enter into the follow-up period, otherwise TME will be operated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Neoadjuvant Chemoradiotherapy | Combination Product | Radiotherapy:45Gy/25F+Boost 50Gy/25F. A total of 45 Gy, 25 fractions of 1.8 Gy, 5 fractions a week CapOx: Capecitabine 1000mg / m² po bid (1-14 days, 21 days a cycle) Oxaliplatin 130mg / m2 igtt(Day 1, 21 days a cycle) TEM or endoscopic local resection |
| Measure | Description | Time Frame |
|---|---|---|
| Organ preservation rate at 3 years | Patients with a good pathological response(ypT 0-1 without neural vascular invasion)after neoadjuvant treatment followed by transanal endoscopic microsurgery(TEM)or endoscopic local resection will be offered an organ preservation strategy | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical complete response rate after neoadjuvant chemoradiotherapy | Define as complete withdrawal of rectal cancer after neoadjuvant radiotherapy and chemotherapy, and no distant metastasis in imaging examination, and no tumor residue in imaging examination and endoscopic biopsy | 18 weeks |
| 3-year local recurrence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Wang, M.D. | Contact | +8613816101686 | wang.jian3@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian Wang, M.D. | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | 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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All the patients will receive neoadjuvant chemoradiotherapy ( CapOx + radiotherapy) for 2 cycles, one week after chemoradiotherapy, the first evaluation including MRI, colonoscopy, digital rectal examination and serum CEA will be conducted. Patients without tumor progression will continue 4 cycles of chemotherapy (CapOx) until next imaging and serum assessment. After the second assessment, for patients with tumor regression and suitable for TEM will receive local resection otherwise TME. Following treatment strategy will be made base on the final pathology evaluation after surgery, patients with good pathological response (ypT 0-1 without neural vascular invasion) will enter into the follow-up period, otherwise TME will be operated.
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Occurrence of local recurrence in patients with an organ preservation strategy |
| 3 years |
| 3-year distant metastases rate | Occurrence of distant metastases in patients with an organ preservation strategy | 3 years |
| 3-year Disease-free survival(DFS)rates | Disease free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distance metastasis or death due to any cause | 3 years |
| 3-year overall survival(OS) rates | OS is defined as the time from enrollment to death due to any cause | 3 years |
| Quality of life (EORTC-QLQ-C 30, psychological status) | Assess QLQ-C30 in patients with an organ preservation strategy | 20 weeks |
| 5-year Disease-free survival(DFS)rates | Disease free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distance metastasis or death due to any cause | 5 years |
| 5-year overall survival(OS) rates | OS is defined as the time from enrollment to death due to any cause | 5 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |