NCT04679597
Completed
Not Applicable
Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure
Overview
- Phase
- Not Applicable
- Intervention
- Capecitabine
- Conditions
- Rectal Cancer
- Sponsor
- Institute of Oncology Ljubljana
- Enrollment
- 161
- Primary Endpoint
- pathological complete response
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
In a retrospective study, the investigators will compare patients with locally advanced rectal cancer with high risk factors for failure who were treated with standard therapy or with total neoadjuvant therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •histologically proven locally advanced rectal cancer and
- •the presence of one of the factors: T4, N2, positive mesorectal fascia, presence of extramural vascular invasion or presence of lateral lymph node.
Exclusion Criteria
- •distant metastases,
- •concomitant malignancy,
- •inflammatory bowel disease, or
- •malabsorption syndrome.
Arms & Interventions
total neoadjuvant therapy
Total neoadjuvant therapy consisted of 12 weeks of induction chemotherapy with CAPOX or FOLFOX, chemoradiotherapy with capecitabine and six to eight weeks of consolidation chemotherapy with CAPOX or FOLFOX prior to surgery.
Intervention: Capecitabine
standard therapy
Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
Intervention: Capecitabine
Outcomes
Primary Outcomes
pathological complete response
Time Frame: during surgery
pathological complete response is defined as the absence of tumor cells in the surgical resection
Secondary Outcomes
- Neoadjuvant rectal cancer score(during treatment, assessed up to 10 days)
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