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