Back to resultsInduction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN (HNO-2)
Primary Purpose
Squamous Cell Carcinoma of the Hypopharynx Stage III, Squamous Cell Carcinoma of the Hypopharynx Stage IV, Squamous Cell Carcinoma of the Larynx Stage III
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
5-fluorouracil
Cetuximab Induction
Cetuximab Radioimmunotherapy
Boost irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Hypopharynx Stage III focused on measuring local advanced squamous cell carcinoma, Larynx, Hypopharynx, Oropharynx, Cavum oris, docetaxel, cisplatin, 5-fluorouracil, Cetuximab
Eligibility Criteria
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
Sites / Locations
- Landeskrankenhaus Feldkirch
- Landesklinikum Krems
- Krankenhaus d. Barmherzigen Schwestern Linz
- Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie
- PMU Salzburg
- Hanusch Krankenhaus Wien
- Universität f. Strahlentherape, AKH Wien
- Klinikum Kreuzschwestern Wels GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Response Rate (CR, PR)
RECIST criteria
Secondary Outcome Measures
Overall Response Rate (CR, PR, PD, SD)
RECIST
Locoregionally monitoring
Progression Free Survival (PFS)
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.
Overall-Survival
Full Information
NCT ID
NCT01884259
First Posted
May 18, 2012
Last Updated
May 20, 2022
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
1. Study Identification
Unique Protocol Identification Number
NCT01884259
Brief Title
Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
January 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
local advanced squamous cell carcinoma, Larynx, Hypopharynx, Oropharynx, Cavum oris, docetaxel, cisplatin, 5-fluorouracil, Cetuximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
75 mg/m² on day 1 of 21-days cycle
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m² on day 1 of 21-days cycle
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Description
750 mg/m² day 1 to 5 during 24 hours of 21-days cycle
Intervention Type
Biological
Intervention Name(s)
Cetuximab Induction
Other Intervention Name(s)
Erbitux
Intervention Description
weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days
Intervention Type
Biological
Intervention Name(s)
Cetuximab Radioimmunotherapy
Other Intervention Name(s)
Erbitux
Intervention Description
weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
Intervention Type
Radiation
Intervention Name(s)
Boost irradiation
Other Intervention Name(s)
Concomitant boost-irradiation
Intervention Description
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
Primary Outcome Measure Information:
Title
Response Rate (CR, PR)
Description
RECIST criteria
Time Frame
3 months after end of therapy
Secondary Outcome Measure Information:
Title
Overall Response Rate (CR, PR, PD, SD)
Description
RECIST
Time Frame
until 3 months after therapy
Title
Locoregionally monitoring
Time Frame
after one year
Title
Progression Free Survival (PFS)
Time Frame
1, 2 and 5 years after start of therapy
Title
Adverse reactions
Description
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.
Time Frame
During treatment and until 60 months after end of radiotherapy
Title
Overall-Survival
Time Frame
1, 2 and 5 years after start of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Keil, Prof.Dr.
Organizational Affiliation
Hanuschkrankenhaus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landeskrankenhaus Feldkirch
City
Feldkirch
ZIP/Postal Code
A-6807
Country
Austria
Facility Name
Landesklinikum Krems
City
Krems
ZIP/Postal Code
A-3500
Country
Austria
Facility Name
Krankenhaus d. Barmherzigen Schwestern Linz
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie
City
Linz
ZIP/Postal Code
A-4021
Country
Austria
Facility Name
PMU Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Hanusch Krankenhaus Wien
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Universität f. Strahlentherape, AKH Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Klinikum Kreuzschwestern Wels GmbH
City
Wels
ZIP/Postal Code
A-4600
Country
Austria
12. IPD Sharing Statement
Links:
URL
http://www.agmt.at
Description
Sponsor
Learn more about this trial
Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN
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