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Squamous Cell Carcinoma of the Hypopharynx Stage IIIPhase 2HNO-2NCT01884259

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

A Phase 2 study testing Docetaxel, Cisplatin and 5-fluorouracil in people with Squamous Cell Carcinoma of the Hypopharynx Stage III and Squamous Cell Carcinoma of the Hypopharynx Stage IV, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 8 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Docetaxel, Cisplatin and 5-fluorouracil
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
8 sitesAustria
Study dates
May 2013to 13 Jan 2022
Phase
Phase 2
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 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Austria8 sites

  • Landeskrankenhaus Feldkirch

    Feldkirch, A-6807

  • Landesklinikum Krems

    Krems, A-3500

  • Krankenhaus d. Barmherzigen Schwestern Linz

    Linz, A-4010

  • Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie

    Linz, A-4021

  • PMU Salzburg

    Salzburg, 5020

  • Hanusch Krankenhaus Wien

    Vienna, 1140

  • Universität f. Strahlentherape, AKH Wien

    Vienna, A-1090

  • Klinikum Kreuzschwestern Wels GmbH

    Wels, A-4600

Other trials in Austria

About this study

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

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

Read the 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.

Being tested
Docetaxel, Cisplatin, 5-fluorouracil, Cetuximab Induction, Cetuximab Radioimmunotherapy
Keywords
local advanced squamous cell carcinoma, Larynx, Hypopharynx, Oropharynx, Cavum oris, docetaxel, cisplatin, 5-fluorouracil, Cetuximab
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Laryngeal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    75 mg/m² on day 1 of 21-days cycle

  • CisplatinDrug

    75 mg/m² on day 1 of 21-days cycle

  • 5-fluorouracilDrug

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

  • Cetuximab InductionBiological

    Also called Erbitux

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

  • Cetuximab RadioimmunotherapyBiological

    Also called Erbitux

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

  • Boost irradiationRadiation

    Also called Concomitant 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

Study groups in NCT01884259
Study groupRoleWhat they receive
AActive comparatorPatients 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.
Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: 5-fluorouracil; Biological: Cetuximab Radioimmunotherapy; Radiation: Boost irradiation
BExperimentalAll 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.
Receives: Drug: Docetaxel; Drug: Cisplatin; Biological: Cetuximab Induction; Biological: Cetuximab Radioimmunotherapy; Radiation: Boost irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate (CR, PR)

    RECIST criteria

    Measured: 3 months after end of therapy

Secondary outcomes (5)

  1. Overall Response Rate (CR, PR, PD, SD)

    RECIST

    Measured: until 3 months after therapy

  2. Locoregionally monitoring

    Measured: after one year

  3. Progression Free Survival (PFS)

    Measured: 1, 2 and 5 years after start of therapy

  4. 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.

    Measured: During treatment and until 60 months after end of radiotherapy

  5. Overall-Survival

    Measured: 1, 2 and 5 years after start of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completion28 Jan 2021
  4. Study completion13 Jan 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01884259
Sponsor's protocol ID
AGMT_HNO 2
Acronym
HNO-2
Status last verified
May 2022
First submitted
18 May 2012
Last updated
26 May 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Cisplatin and 5-fluorouracil in people with Squamous Cell Carcinoma of the Hypopharynx Stage III and Squamous Cell Carcinoma of the Hypopharynx Stage IV, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 8 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 4 inclusion and 8 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 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Response Rate (CR, PR) (time frame: 3 months after end of therapy). 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 NCT01884259.

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 26 May 2022.

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