CompletedNot Applicable

Development and Validation of a Post-operative Risk Of Local Recurrence Model Integrating Serology and Evalution (PROMISE) in Local Advanced Rectal Cancer Receiving Neoadjuvant Therapy: a Multicenter Study

2,315 participantsStarted 2010-01-06

Plain-language summary

Local recurrence (LR) in locally advanced rectal cancer (LARC) correlated with poor survival and impaired quality of life. The aim of this study was to develop and validate machine learning (ML) models integrating clinicopathological features and inflammatory signature to predict LR in LARC patients undergoing neoadjuvant therapy followed by total mesorectal excision.

Who can participate

Age range20 Years – 90 Years

SexALL

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Inclusion criteria

✓. Diagnosed cT\>=3 or cN+ stage rectal cancer by pelvic MRI or enhanced CT scan;
✓. Pathological proved primary rectal adenocarcinoma;
✓. Recieved full-cource radiation or more than 3 cycles of chemotherapy before surgery;
✓. Recieved radical tumor resection by TME surgery.

Exclusion criteria

✕. Diganosed with any distant metastasis disease or locally unresectable disease before neoadjuvant treatment or surgery;
✕. Recieved local resection surgery (R2 resection) or postoperative pathology confirmed positive surgical margins (R1 resection);
✕. Patients who died due to intra- or post-operative complications;
✕. Patient who die or relapse within 30 days after surgery;
✕. Patients who had a prior history of malignancy within 5 years before surgery;
✕. Patients who were loss of follow-up or had inadequate clinical data.

What they're measuring

Local recurrence

Timeframe: From date of randomization until the date of death from local recurrence, assessed up to 120 months

Trial details

NCT IDNCT07351708

SponsorCai Zerong

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Locally Advanced Rectal Cancer (LARC) trials