Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Phase 2Active Not RecruitingNCT05054959

Institute of Oncology Ljubljana62 enrolled

Overview

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.

International recommendations for the treatment of locally advanced rectal cancer with a high risk of disease recurrence are inconsistent regarding the optimal sequence of total neoadjuvant therapy. In a German randomized study, a higher rate of pathological complete response was observed with consolidation chemotherapy. This study compares induction chemotherapy followed by chemoradiotherapy and consolidation chemotherapy with chemoradiotherapy followed by consolidation chemotherapy in patients with locally advanced rectal cancer and high-risk features for recurrence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Rectal Cancer

Interventions

Consolidation CAPOX ChemotherapyDRUG

Six cycles of CAPOX chemotherapy are administered after chemoradiotherapy. CAPOX consists of capecitabine and oxaliplatin according to the study protocol.

Induction CAPOX ChemotherapyDRUG

Four cycles of CAPOX chemotherapy are administered before chemoradiotherapy, followed by two cycles of CAPOX chemotherapy after chemoradiotherapy. CAPOX consists of capecitabine and oxaliplatin according to the study protocol.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Oncology

Ljubljana, Slovenia, Slovenia

Outcomes

Primary Outcomes

complete remission rate

The proportion of complete responses will be defined as the sum of the proportions of pCR in operated patients and cCR in non-operated patients.

Time frame: 2 weeks after completion of TNT

Secondary Outcomes

Overall survival

time from randomization to death

Time frame: after 3 years of follow-up

Survival without recurrence of the disease

time from the end of treatment (in case of cCR) or from radical surgery to death or recurrence of the disease - whichever comes first.

Time frame: after 3 years of follow-up

Disease free survival

the time from the end of treatment (in the case of cCR) or surgery to the recurrence of disease, the onset of new cancer, death from cancer or other causes

Time frame: after 3 years of follow-up

local control

the time from the end of the treatment (in the case of cCR) or surgery to local recurrence

Time frame: after 3 years of follow-up

Data from ClinicalTrials.gov

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