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

NCT ID: NCT04679597

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 161 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-12-31

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.

Conditions

Rectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Capecitabine

Intervention Type: DRUG

comparison of two treatments

standard therapy

Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)

Capecitabine

Intervention Type: DRUG

comparison of two treatments

Interventions

Capecitabine

comparison of two treatments

Intervention Type: DRUG

Other Intervention Names

oxaliplatin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Oncology Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ERID-KSOPKR-0009/2019

Identifier Type: -

Identifier Source: org_study_id