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Laryngeal NeoplasmsPhase 2NCT00941135

Safety and Efficacy Study in Patients With Local Advanced Larynx/Hypolarynx Carcinoma Treated With TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab

A Phase 2 study testing Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab in people with Laryngeal Neoplasms, run by Fundacion Miguel Servet at 4 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To evaluate the progression free time in patients with completed or partial response > 30% evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin, 5-FU) treated with RT + Cetuximab over 2 years. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Laryngeal Neoplasms
What is being tested?
Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab
Type of treatment
Injection or infusion
How many people
70 participants
Where
4 sitesSpain
Study dates
May 2009to May 2013
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient informed consent must be signed before to start the study.
  • Age between 18 to 70 years.
  • Performance Status 0-1 according to ECOG scale at the moment of inclusion.
  • Life expectancy >3 months.
  • Confirmed anatomopathologic diagnosis of local advance scaly larynx or hypolarynx carcinoma III or IV stage without evidence of distance metastasis, which surgery involve a total laryngectomy.
  • T3, T4A, T4B or T2 not candidate to a partial laryngectomy. In case of T2 of both locations it will be required III or IVA stage.
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  • Patients in medical conditions to receive neoadjuvant treatment with TPF followed by hyperfractionated radiotherapy combined with cetuximab.
  • Presence of a injury measurable with RECIST criteria.
  • Neutrophils > or = 1500/mm3, platelets > or = 150.000/mm3 and haemoglobin > or =10 g/dL.
  • Renal Function appropriate
  • Hepatic Function appropriate
  • Serum Calcium tight to albumine < or = 1,25 x upper normal limit (UNL).
  • Nutritional status appropriate: weight loss < 20% and albumine > or = 35 g/L.
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Who cannot join

  • Metastatic disease.
  • Surgical treatment, radiotherapy and/or previous chemotherapy.
  • Another tumour locations in head and neck area different from larynx or hypo larynx.
  • Another stages different from III or IVa without distant metastasis and resectable disease.
  • Another previous scaly carcinoma
  • Diagnosis of another neoplasia in last 5 years, except cervix carcinoma in situ and/or basocellular cutaneous carcinoma adequately treated.
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  • Active infection treated by ATB IV, including active tuberculosis and VIH.
  • Hypertension not controled defined as systolic > or = 180 mm Hg and/or diastolic > or =130 mm Hg at rest.
  • Pregnant/lactating women.
  • Systemic immune treatment, chronic and concomitant, or cancer hormone treatment.
  • Another antineoplastics concomitant treatments.
  • Coronary artery disease or history of heart attack in the last 12 months or high risk of arrythmia uncontrolled or cardiac insufficiency uncontrolled.
  • EPOC that required more than 3 hospitalizations in the last 12 months.
  • Active ulcus not controled.
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Drug abuse (except alcohol abuse)
  • Knowledge of Allergic to study treatment.
  • Previous treatment with Monoclonal antibodies.
  • Any experimental treatment in the previous 30 days to start the study.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Fundación Jiménez Díaz

    Madrid, Madrid, 28040

  • Hospital Carlos Haya

    Málaga, Andalusia, 29010

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: Phase II Study of TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab "Boost Concomitant" With Cetuximab in Patients With Local Advanced Larynx/Hypolarynx Carcinoma

To evaluate the progression free time in patients with completed or partial response > 30% evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin, 5-FU) treated with RT + Cetuximab over 2 years.

Being tested
Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab
Medical subject headings
Laryngeal Neoplasms

What participants receive

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

  • Docetaxel+Cisplatin+5-FU+ Radiotherapy+CetuximabOther

    Also called TPF (Chemotherapy Regimen code)

    Docetaxel:75 mg/m2/d IV Cisplatin:75 mg/m2/d IV 5-FU:750 mg/m2/d IV TPF 3 cycles every 3 weeks

    Radiotherapy: Total 72 Gy in 42 fractions Cetuximab: 250 mg/m2/d Days 1, 8, 15, 22, 29, 36 and 43

What is being measured

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

  1. To evaluate progression-free time in patients with complete or partial response >30% evaluated over primary tumour(T and N) after TPF induction treated with RT + Cetuximab.

    Measured: 2 years

Timeline

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

  1. First posted17 Jul 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionMay 2013 (estimated)
  4. Study completionMay 2013 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00941135
Sponsor's protocol ID
HN2008
Other IDs
EudraCT number: 2008-003365-29
Status last verified
Sep 2011
First submitted
15 Jul 2009
Last updated
29 Sep 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab in people with Laryngeal Neoplasms, run by Fundacion Miguel Servet at 4 sites in Spain.

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 14 inclusion and 19 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: stopped early, as of the sponsor's last update on 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. 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 was stopped early. Results are not available in the source record.

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?

To evaluate progression-free time in patients with complete or partial response >30% evaluated over primary tumour(T and N) after TPF induction treated with RT + Cetuximab. (time frame: 2 years). 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 NCT00941135.

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 29 Sep 2011.

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