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Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer

NCT04134897 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2021-02-09

No results posted yet for this study

Summary

The purpose of this study is to determine whether 3 months of neoadjuvant CapOx is non-inferior to neoadjuvant radiotherapy in patients with moderate risk CRM"-" mid rectal cancer.

Conditions

Interventions

DRUG

Capecitabine

2000 mg/m2, bid, per os, days 1-14, 4 cycles

DRUG

Oxaliplatin

130 mg/m2 iv day 1, 4 cycles

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, 50 Gy on primary tumor

PROCEDURE

Rectal cancer surgery

Laparoscopic or open total mesorectal excision

RADIATION

Radiotherapy

Pelvic radiotherapy dose: 25 Gy in 5 Gy fractions

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
2019-10-14
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 NCT04134897 on ClinicalTrials.gov