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Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN

NCT01884259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-05-26

No results posted yet for this study

Summary

This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.

Conditions

  • Squamous Cell Carcinoma of the Hypopharynx Stage III
  • Squamous Cell Carcinoma of the Hypopharynx Stage IV
  • Squamous Cell Carcinoma of the Larynx Stage III
  • Squamous Cell Carcinoma of the Larynx Stage IV
  • Squamous Cell Carcinoma of the Oropharynx Stage III
  • Squamous Cell Carcinoma of the Oropharynx Stage IV
  • Squamous Cell Carcinoma of the Oral Cavity Stage III
  • Squamous Cell Carcinoma of the Oral Cavity Stage IV

Interventions

DRUG

Docetaxel

75 mg/m² on day 1 of 21-days cycle

DRUG

Cisplatin

75 mg/m² on day 1 of 21-days cycle

DRUG

5-fluorouracil

750 mg/m² day 1 to 5 during 24 hours of 21-days cycle

BIOLOGICAL

Cetuximab Induction

weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days

BIOLOGICAL

Cetuximab Radioimmunotherapy

weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks

RADIATION

Boost irradiation

First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks

Sponsors & Collaborators

  • Arbeitsgemeinschaft medikamentoese Tumortherapie

    lead OTHER

Principal Investigators

  • Felix Keil, Prof.Dr. · Hanuschkrankenhaus

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
2013-05-31
Primary Completion
2021-01-28
Completion
2022-01-13

Countries

  • Austria

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 NCT01884259 on ClinicalTrials.gov