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Capecitabine in the Perioperative Treatment of Rectal Cancer

NCT01500993 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2020-11-27

No results posted yet for this study

Summary

This study compares capecitabine with standard 5-FU in the perioperative treatment of locally advanced rectal cancer.

Conditions

Interventions

DRUG

Capecitabine

Capecitabine standard therapy (i.e. 2,500 mg/sqm) x 5 cycles plus 1 cycle of capecitabine based chemoradiotherapy (1.650 mg/sqm)

DRUG

5-FU

4 cycles of bolus 5-FU (500 mg/sqm) and 1 cycle of 5-FU based chemoradiotherapy (either 1,000 mg/sqm/day infusional 5-Fu days 1-5 and 29-33 or 225 mg/sqm/day infusional 5-Fu throughout the time of chemoradiotherapy)

Sponsors & Collaborators

  • Universitätsmedizin Mannheim

    lead OTHER

Principal Investigators

  • Ralf Hofheinz, MD · Universitätsmedizin Mannheim Germany, University of Heidelberg

  • Frederik Wenz, MD · Universitätsmedizin Mannheim, Germany, University of Heidelberg

  • Stefan Post, MD · Universitätsmedizin Mannheim, Germany, University of Heidelberg

  • Andreas Hochhaus, MD · Universitätsklinikum Jena, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Germany

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 NCT01500993 on ClinicalTrials.gov