Total Neoadjuvant Therapy in Rectal Cancer Treatment

State Scientific Centre of Coloproctology, Russian Federation

Status and phase

Unknown

Phase 4

Conditions

Rectal Cancer

Treatments

Combination Product: Concurrent Chemoradiotherapy

Drug: consolidation chemotherapy

Procedure: TME

Drug: adjuvant chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04747951

127872

Details and patient eligibility

About

This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.

Full description

In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint.

Enrollment

280 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have signed an approved informed consent form for the stud;
Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (сТ2-T4N1-2M0);

Exclusion criteria

rectal cancer recurrence;
Primary-multiple tumours of other localizations;
pelvis radiotherapy in anamnesis;
pregnancy, breastfeeding;
distant metastasis;
ECOG score 3-4

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

280 participants in 2 patient groups

total neoadjuvant therapy

Experimental group

Description:

Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.

Treatment:

Procedure: TME

Drug: adjuvant chemotherapy

Drug: consolidation chemotherapy

Combination Product: Concurrent Chemoradiotherapy

standard therapy

Active Comparator group

Description:

Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)

Treatment:

Procedure: TME

Drug: adjuvant chemotherapy