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The Randomised Study of Preoperative Radiotherapy With Consolidating Chemotherapy for Unresectable Rectal Cancer

NCT00833131 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2010-04-15

No results posted yet for this study

Summary

The addition of Oxaliplatin to conventionally fractionated chemoradiation (FULV or capecitabine) is considered as standard in unresectable rectal cancer by the panel of experts. The Investigators addressed the question whether short-course preoperative radiotherapy with consolidating chemotherapy of FOLFOX4 may increase the rate of R0 resection in patients with unresectable rectal cancer.

Conditions

Interventions

RADIATION

Short course of radiotherapy

5 x 5 Gy and afer one week interval consolidating chemotherapy of 3 courses of FOLFOX4

RADIATION

Radiochemotherapy

28 x 1,8 Gy with simultaneous neoadjuvant chemotherapy: two courses of 5-Fu 325 mg/m2/day i.v. bolus and LV 20 mg/m2/day i.v.-bolus over 5 days given during 1-5 and 29-33 days of radiation. Oxaliplatin is given 50 mg/m2 once a week 5 times during 1, 8, 15, 22 and 29 days of radiation.

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    collaborator OTHER

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Cracow

    collaborator OTHER

  • Poznan University of Medical Sciences

    collaborator OTHER

  • Medical University of Lublin

    collaborator OTHER

  • Polish Colorectal Cancer Study Group

    lead NETWORK

Principal Investigators

  • Krzysztof Bujko, Prof. · Roentgena 5, 02-781 Warsaw, Poland

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
2008-11-30
Primary Completion
2012-11-30
Completion
2015-11-30

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 NCT00833131 on ClinicalTrials.gov