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L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases

NCT01462513 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2018-02-13

No results posted yet for this study

Summary

Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo and saline infusion).

Conditions

  • Colon Carcinoma
  • Rectum Carcinoma

Interventions

BIOLOGICAL

L-BLP25

Treatment: 930µg per treatment once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.

BIOLOGICAL

Placebo

Treatment: Placebo 930µg per treatment, once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.

Sponsors & Collaborators

  • Prof. Dr. Carl Schimanski

    lead OTHER

Principal Investigators

  • Carl Christoph Schimanski, Prof. Dr. · Universitätsmedizin Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT01462513 on ClinicalTrials.gov