Total Neoadjuvant Therapy in Rectal Cancer Treatment

Phase 4

• Conditions: Rectal Cancer
• Interventions: Combination Product: Concurrent Chemoradiotherapy; Procedure: TME; Drug: consolidation chemotherapy; Drug: adjuvant chemotherapy

• Registration Number: NCT04747951
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-10-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-15
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
total neoadjuvant therapy	consolidation chemotherapy	Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
total neoadjuvant therapy	adjuvant chemotherapy	Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
standard therapy	Concurrent Chemoradiotherapy	Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
total neoadjuvant therapy	Concurrent Chemoradiotherapy	Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
standard therapy	TME	Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
standard therapy	adjuvant chemotherapy	Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
total neoadjuvant therapy	TME	Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.

Primary Outcome Measures

Name	Time	Method
The rate of complete responses	3-6 months	The rate of pathological or clinical complete responses

Secondary Outcome Measures

Name	Time	Method
Rate of R0-resections	immediately after surgery	Rate of R0-resections
Rate of compliance with radiotherapy and chemotherapy	6-8 months	Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC)
rate of intraoperative and postoperative complications	0-30 days after surgery	Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation