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| Name | Class |
|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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This was a propensity-score matched observational analysis, comparing the oncological outcome of surgical resection vs watch and wait apporach for rectal cancer patients with a cCR.
Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response from the year 2010 to 2018 were included. Sequential subjects were identified from a prospective maintained database in the Sun Yat-sen University Cancer Center. Clinical experts on rectal cancer from other 5 regional medical centers in China were also invited to participate, and provided data of cCR patients. Standardized forms for data collection were sanded to researchers in each center. Patients received radical resection will constituted our surgery group. Those refused surgery constituted the observation group who went on with the watch and wait approach. A propensity-score matched observational analysis will be used to compare the oncological outcome of these two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observation group | Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response, and refused surgery but went on with the watch and wait approach. | ||
| surgery group | Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response, and received radical resection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard TME surgery | Procedure | radical resection for rectal cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression-free survival | the time from the date of treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | Overall survival was calculated from the date of first treatment until death from any cause or was censored at last follow-up, assessed up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response were included and divided into two groups according to the treatment followed.
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| Name | Affiliation | Role |
|---|---|---|
| Yuan-hong Gao, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | 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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| Fujian Medical University Union Hospital | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Tongji Hospital | OTHER |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |