Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure

Completed

• Conditions: Rectal Cancer
• Interventions: Drug: Capecitabine

• Registration Number: NCT04679597
• Lead Sponsor: Institute of Oncology Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-19
• Study First Posted: 2020-12-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
standard therapy	Capecitabine	Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
total neoadjuvant therapy	Capecitabine	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.

Primary Outcome Measures

Name	Time	Method
pathological complete response	during surgery	pathological complete response is defined as the absence of tumor cells in the surgical resection

Secondary Outcome Measures

Name	Time	Method
Neoadjuvant rectal cancer score	during treatment, assessed up to 10 days	Neoadjuvant rectal cancer score: The NAR score was calculated using the equation \[5 pN - 3(cT - pT) + 12\]\^2 / 9.61 and further classified as low (\< 8), intermediate (8-16), or high (\< 16).