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Active Not Recruiting NCT05054959

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Conditions: Locally Advanced Rectal Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 62
Sponsor: Institute of Oncology Ljubljana

Location: Institute of Oncology Ljubljana Slovenia

Summary

The purpose of this study is to identify the most promising treatment sequence in total neoadjuvant therapy for locally advanced rectal cancer with a high risk of recurrence.

Eligibility Criteria

Inclusion Criteria:- histologically proven rectal adenocarcinoma * no distant metastases on CT scan (M0 disease) * at least one high risk factor for disease recurrence identified on magnetic resonance imaging (MRI): * T4 tumor (cT4) * N2 disease (cN2) * extramural venous invasion (cEMVI+) * positive lateral lymph nodes * distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+) * capacity for informed consent * willingness to attend regular check-ups during and after treatment Exclusion Criteria:history of previous irradiation in the pelvic area * absolute contraindications for MR imaging * distant metastases cannot be reliably excluded * synchronous cancer * chronic inflammatory bowel disease

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05054959). StuddyBuddy aggregates publicly available trial information.