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| Name | Class |
|---|---|
| Complejo Hospitalario Universitario de Santiago | OTHER |
| Hospital Universitario Marqués de Valdecilla | OTHER |
| Hospital de Sant Joan Despí Moisès Broggi | OTHER |
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The investigators evaluate the response of rectal cancer to neoadjuvant therapy and classify the response according to specific periods of time after the end of neoadjuvant treatment.
In the treatment of locally advanced rectal cancer, an optimal interval between neoadjuvant therapy and surgery might improve oncological outcomes. Besides, those patients who achieve a good response might benefit from active surveillance, avoiding surgical comorbidities. This optimal interval is yet to be defined. This study will aim to better define the role of time interval between the end of neoadjuvant therapy (NAT) and TME in Spanish regions, together with analyzing the importance of restaging MRI and define the basis for implementing a "watch and wait" protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short interval group | ≤ 8weeks between the end of neoadjuvant therapy and surgery |
| |
| Intermediate interval group | > 8 and ≤ 12 weeks between the end of neoadjuvant therapy and surgery |
| |
| Long interval group | > 12 weeks between the end of neoadjuvant therapy and surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interval between NAT and surgery | Procedure | Evaluate three groups according to the interval between the end of neoadjuvant therapy and surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response | Grade as complete | 2000-2019 |
| Circumferential margin (CRM) | Described as free (CRM >1 mm) | 2000-2019 |
| Distal resection margin (DRM) | Described as free (DRM >1 mm) | 2000-2019 |
| Quality of the specimen | Described as complete or incomplete | 2000-2019 |
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Inclusion Criteria:
Exclusion Criteria:
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This was a national multicentre retrospective cohort study. Participating centres are tertiary referral hospitals from different Spanish regions, which agreed to enter information in a standardized database, of all patients in their institute who had biopsy-confirmed rectal adenocarcinoma and had received neoadjuvant therapy. All patients with low, mid and high rectal cancer (0-15 cm from the anal verge), at a clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Lacy, PhD | Hospital Clinic of Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
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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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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Hospital del Mar |
| OTHER |
| Hospital Son Espases | OTHER |
| Hospital Universitario La Fe | OTHER |
| Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | OTHER |
| Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion | OTHER |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |