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

Squamous Cell Carcinoma of the Hypopharynx Stage III Clinical Trial

— HNO-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884259
• Other study ID #: AGMT_HNO 2
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: January 13, 2022

Study information

• Verified date: May 2022
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 13, 2022
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Laryngeal Diseases
• Laryngeal Neoplasms
• Oropharyngeal Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• 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 Oral Cavity Stage III
• Squamous Cell Carcinoma of the Oral Cavity Stage IV
• Squamous Cell Carcinoma of the Oropharynx Stage III
• Squamous Cell Carcinoma of the Oropharynx Stage IV

Intervention

Drug:
• Docetaxel
75 mg/m² on day 1 of 21-days cycle
• Cisplatin
75 mg/m² on day 1 of 21-days cycle
• 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
• 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

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldkirch	Feldkirch
Austria	Landesklinikum Krems	Krems
Austria	Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie	Linz
Austria	Krankenhaus d. Barmherzigen Schwestern Linz	Linz
Austria	PMU Salzburg	Salzburg
Austria	Hanusch Krankenhaus Wien	Vienna
Austria	Universität f. Strahlentherape, AKH Wien	Vienna
Austria	Klinikum Kreuzschwestern Wels GmbH	Wels

Sponsors (1)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate (CR, PR)	RECIST criteria	3 months after end of therapy
Secondary	Overall Response Rate (CR, PR, PD, SD)	RECIST	until 3 months after therapy
Secondary	Locoregionally monitoring		after one year
Secondary	Progression Free Survival (PFS)		1, 2 and 5 years after start of therapy
Secondary	Adverse reactions	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
Secondary	Overall-Survival		1, 2 and 5 years after start of therapy

External Links

•   Sponsor