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Induction and Consolidation Chemotherapy in Patients With Locally Advanced CRM-positive Rectal Cancer

NCT04135313 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2021-02-09

No results posted yet for this study

Summary

The purpose of this study is to determine whether the addition of 2 cycles of induction CapOx chemotherapy and 2 cycles of consolidation CapOx chemotherapy to standard chemoradiation improves 3-year disease-free survival in patients with locally advanced CRM"+" mid and low rectal cancer.

Conditions

Interventions

DRUG

Capecitabine

2000 mg/m2, bid, per os, days 1-14

DRUG

Oxaliplatin

130 mg/m2 iv day 1

DRUG

Capecitabine

825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)

RADIATION

Radiotherapy

Pelvic radiotherapy dose: 44 Gy on regional nodes, 54 Gy on primary tumor in 2 Gy fractions

PROCEDURE

Rectal cancer surgery

Laparoscopic or open total mesorectal excision or extralevator abdominoperineal resection

Sponsors & Collaborators

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Principal Investigators

  • Zaman Z Mamedli, PhD · N.N.Blokhin Russian Cancer Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-20
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04135313 on ClinicalTrials.gov