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Reduced Radiotherapy With Pac/Cis vs Standard Radiotherapy With 5-FU/Cis in Locally Advanced Head and Neck Cancer

NCT01126216 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2021-05-04

No results posted yet for this study

Summary

Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis

Conditions

Interventions

DRUG

Paclitaxel/Cisplatin

Experimental: Paclitaxel (20mg/m\^2/d) on days 2, 5, 8, 11 and 25, 30, 33, 36) and Cisplatin (20mg/m\^2/d) on days 1-4 and 29-32,

RADIATION

Reduced RT

Experimental: 63,6 Gy accelerated hyperfractionated radiotherapy

DRUG

5-FU/Cisplatin

Active Comparator: 5-Fluorouracil(600mg/m\^2/d) on days 1-5 and 29-33) and Cisplatin (20mg/m\^2/d) on days 1-5 and 29-33

RADIATION

Standard RT

Active Comparator: 70,6 Gy accelerated hyperfractionated radiotherapy

Sponsors & Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Rainer Fietkau, MD · Strahlenklinik, Universitätsklinikum Erlangen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2015-06-30
Completion
2019-06-30

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 NCT01126216 on ClinicalTrials.gov