An observational study in Rectal Cancer and Neoadjuvant Therapy, sponsored by Hospital Clinic of Barcelona. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Hospital Clinic of Barcelona · Observational
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 911 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
≤ 8weeks between the end of neoadjuvant therapy and surgery
Procedure: Interval between NAT and surgery
\> 8 and ≤ 12 weeks between the end of neoadjuvant therapy and surgery
Procedure: Interval between NAT and surgery
\> 12 weeks between the end of neoadjuvant therapy and surgery
Evaluate three groups according to the interval between the end of neoadjuvant therapy and surgery.
Pathological response
Grade as complete
Time frame: 2000-2019
Circumferential margin (CRM)
Described as free (CRM \>1 mm)
Time frame: 2000-2019
Distal resection margin (DRM)
Described as free (DRM \>1 mm)
Time frame: 2000-2019
Quality of the specimen
Described as complete or incomplete
Time frame: 2000-2019
Plan to share: No
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This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Hospital Clinic of Barcelona