Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN (HNO-2)

May 20, 2022 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

Randomised Phase II Pilot Study: Induction Chemotherapy With Docetaxel, Cisplatin and Cetuximab Versus Docetaxel, Cisplatin and 5 FU Followed by Radiotherapy With Cetuximab for Locally Advanced or Not Resectable Carcinoma of the Head and Neck

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It will be evaluated whether 5-FU can be replaced by immunotherapy with cetuximab within a taxane/cisplatin-containing induction-chemotherapy scheme for advanced carcinoma of the head and neck. As 5-FU causes severe mucosal toxicities which are added to known toxicities of cisplatin, a combination-therapy with reduced toxicities and same efficacy would be a acceptable alternative to patients.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, A-6807
        • Landeskrankenhaus Feldkirch
      • Krems, Austria, A-3500
        • Landesklinikum Krems
      • Linz, Austria, A-4010
        • Krankenhaus d. Barmherzigen Schwestern Linz
      • Linz, Austria, A-4021
        • Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie
      • Salzburg, Austria, 5020
        • PMU Salzburg
      • Vienna, Austria, 1140
        • Hanusch Krankenhaus Wien
      • Vienna, Austria, A-1090
        • Universität f. Strahlentherape, AKH Wien
      • Wels, Austria, A-4600
        • Klinikum Kreuzschwestern Wels GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris stage III and IV
  • One measureable lesion (CT oder MR)
  • Age 18 - 75 (including)
  • Performance Score ECOG 0 - 1

Exclusion Criteria selected:

  • Distant metastases
  • ECOG Score >1
  • Prior radiation (Head and neck area)
  • Creatinin Clearance below 60 ml/µl
  • Acute infections
  • Neuropathy grade 3 or 4
  • Myocardial Infarction within the last 12 months
  • Acute coronary syndrome or othe clinically significant cardiovascular diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A

Patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) and 5-fluorouracil (750mg/m²) followed by Cetuximab (weekly, starting with 400mg/m² then continuing with 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks).

Active comparator is 5-fluorouracil for first three cycles.
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 Radioimmunotherapy
weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
Other Names:
  • Erbitux
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
Other Names:
  • Concomitant boost-irradiation
EXPERIMENTAL: B

All patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) Cetuximab (weekly, starting with 400mg/m² and continuing with 250 mg/m²), followed by Cetuximab (weekly 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks).

Experimental: cetuximab for the first three cycles.
Drug: Docetaxel
75 mg/m² on day 1 of 21-days cycle
Drug: Cisplatin
75 mg/m² on day 1 of 21-days cycle
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
Other Names:
  • Erbitux
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
Other Names:
  • Concomitant boost-irradiation
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
Other Names:
  • Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (CR, PR)
Time Frame: 3 months after end of therapy
RECIST criteria
3 months after end of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (CR, PR, PD, SD)
Time Frame: until 3 months after therapy
RECIST
until 3 months after therapy
Locoregionally monitoring
Time Frame: after one year
after one year
Progression Free Survival (PFS)
Time Frame: 1, 2 and 5 years after start of therapy
1, 2 and 5 years after start of therapy
Adverse reactions
Time Frame: During treatment and until 60 months after end of radiotherapy

Information about acute toxicity (grade, relation to study drug) during study treatment and until 3 months after end of radiotherapy will be collected for each patient using CTCAE 3.0 criteria list.

Information about late toxicity (grade) will be collected after 3 months of radiotherapy and until 60 months after radiotherapy using RTOG/EORTC toxicity criteria.

Kind and number of toxicities will be described according to grade. The highest grade of each patient and toxicity will be analysed.
During treatment and until 60 months after end of radiotherapy
Overall-Survival
Time Frame: 1, 2 and 5 years after start of therapy
1, 2 and 5 years after start of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

January 28, 2021

Study Completion (ACTUAL)

January 13, 2022

Study Registration Dates

First Submitted

May 18, 2012

First Submitted That Met QC Criteria

June 20, 2013

First Posted (ESTIMATE)

June 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGMT_HNO 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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