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Neoadjuvant Chemotherapy in Patients With Intermediate Risk Upper and Mid Rectal Cancer

NCT04103697 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2021-02-09

No results posted yet for this study

Summary

The purpose of this study is to determine whether 4 cycles of neoadjuvant CapOx chemotherapy is more effective than the upfront surgery in patients with intermediate risk CRM"-" mid and upper 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 partial or total mesorectal excision (based on exact tumor location and surgeons discretion)

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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2024-08-31
Completion
2024-08-31

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 NCT04103697 on ClinicalTrials.gov