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Head and Neck CancerPhase 2NCT00765011

TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx Cancer

A Phase 2 study testing TPF, radiotherapy and cetuximab and H&N surgery in people with Head and Neck Cancer, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 17 sites in Spain.

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

A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF Chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
TPF, radiotherapy and cetuximab and H&N surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
17 sitesSpain
Study dates
Oct 2008to 12 May 2015
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

  • Signed Informed Consent Form.
  • Men or women, age (18 and 70).
  • ECOG scale:0-1.
  • Life expectancy superior to 3 months.
  • Larynx squamous carcinoma histologically demonstrated.
  • Patients with larynx squamous carcinoma, stage III-IVA, with resectable disease whose surgery will imply a total laryngectomy. The T should be a T3, T4A, or a T2 not candidate for a partial laryngectomy. In case of T2 of any of both locations it will be required a III or IVA stadium.
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  • Patients to be able to receive treatment with TPF followed by normofractionated radiotherapy with cetuximab.
  • Measurable disease (OMS criteria).
  • Neutrophils superior or equal to 1500/mm3, platelets superior or equal to 150.000/mm3, hemoglobin superior or equal to 10 g/dl.
  • Adequate renal function: creatinin lower or equal to 120 µmol/l (1,4mg/dl)
  • Adequate hepatic function: bilirubin lower or equal to 1 x UNL, AST and ALT lower or equal to 2,5 UNL, alkaline phosphatase lower or equal to 5 UNL.
  • Seric calcium adjusted to albumine lower or equal to 1,25 UNL.
  • Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.
  • Use of an effective contraceptive method.

Who cannot join

  • Metastatic disease
  • Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.
  • Other tumour locations in H\&N that are not larynx.
  • Other stages that are not III or IVa without metastasis and resectable disease.
  • The following cases, which will be considered candidates for radical surgery, will not be included in the study:
  • Tumors of the subglottis.
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  • Tumors of glottis or supraglottis with subglottal extension
  • Tumor that destroys the thyroid cartilage and/or cricoid and it extends to thyroid gland or soft necks's tissues.
  • Tumor of supraglottis with a superior extension to 1 cm towards the tongue base (the extension will be measured since the vallecula).
  • Other previous and/or synchronic squamous carcinoma.
  • Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.
  • Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.
  • Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg and/or diastolic arterial tension superior or equal to 130 mm Hg baseline.
  • Pregnancy or breastfeeding.
  • Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.
  • Other antineoplasic concomitant treatments.
  • Coronary clinically significant arteriopathy or precedents of myocardial infarction in the last 12 months or high risk of not controlled arrhythmia or cardiac not controlled insufficiency.
  • Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months.
  • Active non controlled peptic ulcer.
  • Presence of a psychological or medical disease that could prevent to accomplish the study by the patient or to grant his/her signature in the informed consent form.
  • Known drugs abuse (excepting excessive consumption of alcohol).
  • Known allergic reaction to some of the components of the treatment of the study.
  • Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR.
  • Any experimental treatment in 30 days before entry in the study.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Spain17 sites

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital San Pedro de Alcántara

    Cáceres

  • Hospital Dr.Josep Trueta (ICO Girona)

    Girona, 17007

  • Hospital Universitario Virgen de las Nieves

    Granada

  • Oncogranada

    Granada

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona

  • Hospital Xeral Calde

    Lugo

  • Hospital Gregorio Marañon

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario San Carlos

    Madrid

  • Hospital de Manresa

    Manresa, Barcelona

  • Hospital Son Llátzer

    Palma de Mallorca

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital Universitario la Fe de Valencia

    Valencia

  • Hospital Clínico Universitario de Zaragoza

    Zaragoza

  • Hospital Miguel Servet

    Zaragoza

Other trials in Spain

About this study

Official title: A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF

A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF Chemotherapy.

Read the detailed description

This study is being sponsored by a cooperative medical group.

Being tested
TPF, radiotherapy and cetuximab, H&N surgery
Keywords
Head and Neck Cancer
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.

  • TPF, radiotherapy and cetuximabDrug

    Also called TPF plus radiotherapy and cetuximab

    3 cycles of: cisplatin: 75mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracilo: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy,divided into daily doses of 2 Gray (total days:35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days

  • H&N surgeryProcedure or surgery

    Also called Rescue surgery

    Rescue surgery

Study groups in NCT00765011
Study groupRoleWhat they receive
Group AExperimentalTPF plus concomitant treatment with cetuximab and conventional radiotherapy
Receives: Drug: TPF, radiotherapy and cetuximab
Grupo BOtherSurgery
Receives: Procedure: H&N surgery

What is being measured

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

  1. Specific survival free of total laryngectomy

    Time from the start of TPF treatment to death caused by the disease or by the treatment of the disease, or even to surgery involving total laryngectomy. Deaths caused by other reasons were considered "censored" data on the date of death.

    Measured: Three years after the end of treatment with radiotherapy and cetuximab

Timeline

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

  1. First posted2 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionFeb 2014
  4. Study completion12 May 2015

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
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00765011
Sponsor's protocol ID
TTCC-2007-02
Status last verified
Apr 2019
First submitted
1 Oct 2008
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TPF, radiotherapy and cetuximab and H&N surgery in people with Head and Neck Cancer, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 17 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 24 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 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 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?

Specific survival free of total laryngectomy (time frame: Three years after the end of treatment with radiotherapy and cetuximab). 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 NCT00765011.

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 11 Apr 2019.

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