Neoadjuvant Therapy, Rectal Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREInterval between NAT and surgery
Evaluate three groups according to the interval between the end of neoadjuvant therapy and surgery.
Sponsors
Complejo Hospitalario Universitario de Santiago
Hospital Universitario Marqués de Valdecilla
Hospital de Sant Joan Despí Moisès Broggi
Hospital del Mar
Hospital Son Espases
Hospital Universitario La Fe
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
Hospital Clinic of Barcelona
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Adult patients suitable for elective surgical resection of biopsy-confirmed rectal adenocarcinoma (0-15 cm from the anal verge) determined by rectal cancer protocol magnetic resonance imaging. * Patients treated with long-course neoadjuvant chemoradiotherapy (nCRT). * Patients treated with short-course radiotherapy with delayed surgery. * Clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) determined by rectal cancer protocol magnetic resonance imaging
Exclusion criteria
* Intolerance or contraindication to planned NAT. * Patients who have not finished NAT for any reason. * Patients with unknown cT or cM. * Tumors previously treated with local excision or with distant metastatic disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological response | 2000-2019 | Grade as complete |
| Circumferential margin (CRM) | 2000-2019 | Described as free (CRM \>1 mm) |
| Distal resection margin (DRM) | 2000-2019 | Described as free (DRM \>1 mm) |
| Quality of the specimen | 2000-2019 | Described as complete or incomplete |
Countries
Spain
Outcome results
None listed