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Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. As a result, clinical complete response (cCR), defined as no clinical detectable tumor by physical examination, endoscopic evaluation, and imaging, is designed as a surrogate endpoint for pCR. However, the concordance between cCR and pCR varies from 22% to 96% in different reports, which questions the clinical value of such strategies. Therefore, based on rectal diginal examination, serum CEA, MRI, endoscopy examination, we suggested to add multi-points and full-thickness biopsy technique to further improve the accuracy of cCR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy cCR | Experimental | Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, we add multi-points and full-thickness Biopsy to further improve the accuracy of cCR after neoadjuvant therapy for rectal cancer. |
|
| Conventional cCR | Active Comparator | Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, to study accuracy of cCR after neoadjuvant therapy for rectal cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-points and full-thickness Biopsy | Procedure | Four points around the tumor site and center of the tumor site full-thickness Biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Complete Response rate | Clinical complete response rate between two groups after examinations following preoperative chemoradiotherapy for rectal cancer | 8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer |
| pathological complete remission | No tumor cell found in surgical specimens | 2 weeks after patients received radical operation |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | no tumor regrowth or recurrence or metastasis found | 5 years after operation or "watch and wait" approach |
| Overall Survival | survive during following |
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Inclusion Criteria:
Exclusion Criteria:
Previous history of malignant colorectal tumor;
Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery;
Unresectable lymph node metastasis;
Recently diagnosed with other malignant tumors;
Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment;
ASA rating ≥IV and/or ECOG physical status score ≥2 points;
Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases cannot tolerate surgery;
a history of serious mental illness;
- pregnant or lactating women;
Those with uncontrolled infection;
Patients with other clinical or laboratory conditions considered by the investigator should not participate in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiagang Han | Contact | 86-10-85231604 | hanjiagang@ccmu.edu.cn | |
| Zhiwei Zhai | Contact | 86-10-85231604 | 913916215@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenjun Wang | Beijing Chao Yang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital | Recruiting | Beijing | Beijing Municipality | 100020 | China |
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| traditional cCR | Diagnostic Test | diginal examination, endoscopy test, rectal MRI, and serum CEA level |
|
| 5 years after operation or "watch and wait" approach |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D000095384 | Pathologic Complete Response |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
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