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Pathologic complete response (pCR) after multimodal treatment for locally advanced rectal cancer (LARC) patients is considered as the gold-standard of treatment success as it is associated to privileged oncologic outcome. Nevertheless, data from multicenter high-volume cohorts with long term follow-up are scarce.
This is a multicenter observational study using prospectively collected data from the Spanish Rectal Cancer Project database.
The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
Secondary objective is to analyze demographic, clinical, operative and treatment variables in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
The results are reported in accordance with the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Statement for observational studies.
All calculations are performed using Stata 13.1 (StataCorp, Texas, USA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NON-DISTANT METASTASES | Those patiens who do not develop distant metastasis during the follow-up time. |
| |
| DISTANT METASTASES | Those patiens who develop distant metastasis during the follow-up time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant treatment | Procedure | We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR. | Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR. | May 2022-June 2022 |
| Measure | Description | Time Frame |
|---|---|---|
| To analyze operative and treatment data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths. | Operative and treatment data related to adverse oncologic outcomes. | May 2022-June 2022 |
| To analyze demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital La Princesa | Madrid | Spain |
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Age (years) related to worse long-term oncologic outcomes. |
| May 2022-June 2022 |
| To analyze further demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths. | Normal Pretreatment CEA (ng/dl) related to worse long-term oncologic outcomes. | May 2022-June 2022 |
| To analyze clinical data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths. | Tumour location (cm) and Distance from anal verge (cm) related to worse long-term oncologic outcomes. | May 2022-June 2022 |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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