Head and Neck CancerASOG-HNO1NCT00502463
Induction Chemotherapy Prior to Radio-immunotherapy in Head and Neck Cancer Stage III/IV - a Methodical Trial
A study testing Docetaxel, Cisplatin and 5-FU in people with Head and Neck Cancer, run by Austrian South Oncology Group at 5 sites in Austria.
Trial summary
The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Docetaxel, Cisplatin and 5-FU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesAustria
- Study dates
- 3 Oct 2007to 19 Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed, locally advanced head and neck cancer
- stage III/IV
- performance status: ECOG 0-1
Who cannot join
- distant metastases
- prior radiotherapy of the head and neck region
- myocardial infarct in the last six months
- florid peptic ulcer
- neuropathy grade III/IV
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Austria5 sites
LKH Feldkirch, Dept. of Radiooncology
Feldkirch, 6807
Medical University of Graz, Dept. of Radiooncology
Graz, 8036
LKH Leoben Dept. of Hemato-Oncology
Leoben, 8700
UK Salzburg, LKH: Universitätsklinik für Innere Medizin III
Salzburg, 5020
Medical University of Vienna, Dept. of Medicine I
Vienna, 1090
About this study
Official title: Induction by Docetaxel/Cisplatin/5-Fluorouracil (TCF) Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial
The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV
Read the detailed description
3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days;
Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, stage III/IV, no prior radiotherapy of head and neck region
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
75mg/m² day 1
CisplatinDrug
75mg/m² day 1
5-FUDrug
750mg/m²/day day 1-5
RadiotherapyRadiation
standard fraction up to a total dose of 70Gy/35 fractions/7weeks or accelerated regimen, up to a total dose of 72Gy/42 fractions over 6 weeks
CetuximabDrug
250mg/m²/week after an initial loading dose of 400mg/m²
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | 3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: 5-FU; Radiation: Radiotherapy; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional tumour control
Time without progression of locoregional disease, locoregional recurrence of disease or death from any cause after one year.
Measured: 12 months
Secondary outcomes (4)
Response rate
PET-CT or CT, RECIST criteria
Measured: 24 months
Progression free survival
PFS is calculated from start of therapy until disease progression or death from any cause.
Measured: 24 months
Overall survival
OS is calculated from start of therapy to death from any cause.
Measured: 24 months
Toxicities
The highest grade of a toxicity per patient is included in the analysis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study start3 Oct 2007
- Primary completion19 Jan 2010
- Study completion19 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian South Oncology Group
- Sponsor type
- Research network
- Collaborators
- Change of sponsor 2008: new sponsor AGMT
- Responsible party
- Sponsor
- Investigators
- Felix Keil, MD, Study chair, LKH Leoben, Dept. for Hemato-Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502463
- Sponsor's protocol ID
- AGMT_HNO
- Acronym
- ASOG-HNO1
- Status last verified
- Feb 2024
- First submitted
- 15 Jul 2007
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Keil F, Selzer E, Berghold A, Reinisch S, Kapp KS, De Vries A, Greil R, Bachtiary B, Tinchon C, Anderhuber W, Burian M, Kasparek AK, Elsasser W, Kainz H, Riedl R, Kopp M, Kornek G. Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by radiotherapy with cetuximab for locally advanced squamous cell carcinoma of the head and neck. Eur J Cancer. 2013 Jan;49(2):352-9. doi: 10.1016/j.ejca.2012.08.004. Epub 2012 Sep 14.
PubMed 22981499
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction by Docetaxel/Cisplatin/5-Fluorouracil (TCF) Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial
- ClinicalTrials.gov ID
- NCT00502463
- Acronym / sponsor ID
- ASOG-HNO1 / AGMT_HNO
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, stage III/IV, no prior radiotherapy of head and neck region
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Austrian South Oncology GroupResearch network
- Collaborators
- Change of sponsor 2008: new sponsor AGMT
- Study start
- 3 Oct 2007 (actual)
- Primary completion
- 19 Jan 2010 (actual)
- Study completion
- 19 Jan 2014 (actual)
- First posted
- 17 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV
Detailed description
3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days;
Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Docetaxel, Drug: Cisplatin, Drug: 5-FU, Radiation: Radiotherapy, Drug: Cetuximab3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- histologically confirmed, locally advanced head and neck cancer
- stage III/IV
- performance status: ECOG 0-1
Key exclusion criteria (5 listed)
- distant metastases
- prior radiotherapy of the head and neck region
- myocardial infarct in the last six months
- florid peptic ulcer
- neuropathy grade III/IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel75mg/m² day 1 | Drug | Single Arm |
| Cisplatin75mg/m² day 1 | Drug | Single Arm |
| 5-FU750mg/m²/day day 1-5 | Drug | Single Arm |
| Radiotherapystandard fraction up to a total dose of 70Gy/35 fractions/7weeks or accelerated regimen, up to a total dose of 72Gy/42 fractions over 6 weeks | Radiation | Single Arm |
| Cetuximab250mg/m²/week after an initial loading dose of 400mg/m² | Drug | Single Arm |
Primary outcome
Locoregional tumour control
Time frame: 12 months
Time without progression of locoregional disease, locoregional recurrence of disease or death from any cause after one year.
4 secondary outcomes
Response rate
Time frame: 24 months
Progression free survival
Time frame: 24 months
Overall survival
Time frame: 24 months
Toxicities
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Results publication: PubMed 22981499Keil F, Selzer E, Berghold A, Reinisch S, Kapp KS, De Vries A, Greil R, Bachtiary B, Tinchon C, Anderhuber W, Burian M, Kasparek AK, Elsasser W, Kainz H, Riedl R, Kopp M, Kornek G. Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by radiotherapy with cetuximab for locally advanced squamous cell carcinoma of the head and neck. Eur J Cancer. 2013 Jan;49(2):352-9. doi: 10.1016/j.ejca.2012.08.004. Epub 2012 Sep 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Keil, MD study chair
LKH Leoben, Dept. for Hemato-Oncology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docetaxel, Cisplatin and 5-FU in people with Head and Neck Cancer, run by Austrian South Oncology Group at 5 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional tumour control (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00502463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.