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

Institute of Oncology Ljubljana

Status: Completed

Conditions: Rectal Cancer

Treatments: Drug: Capecitabine

Study type: Observational

Funder types: Other

Identifiers

NCT04679597

ERID-KSOPKR-0009/2019

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

161 participants in 2 patient groups

total neoadjuvant therapy

Description:

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.

Treatment:

Drug: Capecitabine

standard therapy

Description:

Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)

Treatment:

Drug: Capecitabine