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Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

NCT01444495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-02-15

No results posted yet for this study

Summary

The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.

Conditions

Interventions

RADIATION

Preoperative radiotherapy

Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)

PROCEDURE

Surgery

Total mesorectal excision of rectal cancer

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Jan Kulig, Prof. · First Department of General Surgery, Jagiellonian University

  • Radoslaw Pach, Ph.D. · First Department of General Surgery, Jagiellonian University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-01-31
Primary Completion
2008-06-30
Completion
2010-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

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 NCT01444495 on ClinicalTrials.gov