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Comparative Study of Individualized Sensitivity-Directed Chemotherapy Versus DTIC

NCT00779714 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2008-10-24

No results posted yet for this study

Summary

This phase III trial is aimed to investigate the efficacy of an individualized, sensitivity-directed combination chemotherapy in comparison to the standard regimen DTIC.

Two question are aimed to be answered by this study:

1. Is the individual chemosensitivity index (BICSI) a prognostic / predictive biomarker for chemotherapy ?
2. Is an individualized, sensitivity-directed combination chemotherapy superior to the standard regimen DTIC in terms of survival and response ?

Conditions

Interventions

DRUG

DTIC (dacarbazine)

1000 mg/m2, d1 every 21 days

DRUG

paclitaxel + cisplatin

paclitaxel 200 mg/m2 cisplatin 50 mg/m2 d1 every 21 days

DRUG

treosulfan + cytarabine

treosulfan 2500 mg/m2, d2 cytarabine 100 mg/m2, d1-3 every 21 days

Sponsors & Collaborators

  • Hiege-Stiftung gegen Hautkrebs

    collaborator UNKNOWN

  • medac GmbH

    collaborator INDUSTRY

  • DCS Innovative Diagnostik Systeme

    collaborator UNKNOWN

  • University of Wuerzburg

    lead OTHER

Principal Investigators

  • Selma Ugurel, Prof. (MD) · Dept of Dermatology, University of Wuerzburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-10-31
Completion
2013-04-30

Countries

  • Germany

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 NCT00779714 on ClinicalTrials.gov