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Head and Neck CancerPhase 3NCT00716391

TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.

A Phase 3 study testing TPF, radiotherapy and cisplatin. and TPF, radiotherapy and cetuximab. in people with Head and Neck Cancer, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 39 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

An Open Label Randomized, Multi-Centre Phase III Trial of TPF Chemotherapy Plus Concomitant Treatment With Cisplatin and Conventional Radiotherapy Versus TPF Chemotherapy Plus Concomitant Cetuximab and Conventional Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer. 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 cisplatin. and TPF, radiotherapy and cetuximab.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
519 participants
Where
39 sitesSpain
Study dates
7 Jul 2008to Dec 2017
Phase
Phase 3
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

  • Before the beginning of protocol's specific procedures, the informed consent has to be obtained.
  • Locally advanced cancer of head and neck (oral cavity, oropharynx, larynx and hypopharynx) stage III-IV, without evidence of metastasis.
  • The tumor must be considered to be non-operable according to the criteria of the Northern California Oncology Group. The reason of non-surgical resection will be annotated in the CRF.
  • Criteria of non-surgical resection according to the NCOG:
  • 3.1.Technically not resectable (includes: evidence of mediastinal dissemination; fixed tumor to the clavicle, base of the cranium or cervical vertebrae; affectation of the nasopharynx).
  • 3.2.Medical criteria based on a low surgical curability. 3.3.Medical contraindication for the surgery.
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  • Epidermoid carcinoma histologically demonstrated
  • Measurable disease according to the RECIST criteria .
  • Men or women with age between 18 and 70 years, both inclusive.
  • Functional condition index according to ECOG scale:0-1
  • Patients in medical conditions to be able to receive treatment with TPF induction followed by normofractionated radiotherapy with cetuximab or cisplatin.
  • Patients with adequate hematologic function: neutrophils superior or equal to 2 x 109, platelets superior or equal to 100 x 109, hemoglobin superior or equal to 10 g/dl.
  • Adequate hepatic function: bilirubin lower or equal to 1 x top normal Limit, GOT and GPT lower or equal to 2,5 Top Normal Limit , alkaline phosphatase < 5 Top Normal Limit.
  • Adequate renal function: creatinin <1,4 mg/dl (120 µmol/l); if the values are > 1,4 mg/dl, the clearance of creatinin will have to be > 60 ml/min (real or calculated for Cockcroft-Gault's method).
  • Calcium lower or equal to 1,25 x top normal limit.
  • Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.
  • Patients must be accessible for the treatment and the follow-up.

Who cannot join

  • Metastatic disease
  • Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.
  • Other tumor locations in head and neck that are not oral cavity, oropharynx, larynx, hypopharynx.
  • Other stages that are not III or IVM0.
  • 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.
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  • 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(absence must be confirmed with the test of beta-HCG) or period of lactation.
  • Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.
  • Other antineoplastic 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 (with the exception of 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 the entry in the study.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Spain39 sites

  • Hospital general Universitario

    Alicante

  • Hospital Puerta del Mar

    Almería, Almería

  • Hospital Nuestra Señora de Sonsoles

    Ávila

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital de Basurto

    Bilbao

  • Hospital General Yagüe

    Burgos

  • Hospital San Pedro de Alcántara

    Cáceres

  • Hospital Dr. Trueta (ICO Girona)

    Girona, 17007

  • Oncogranada

    Granada, 18014

  • H. Virgen de las Nieves

    Granada

  • Hospital Durán i Reynals

    Hospitalet de Ll., Barcelona

  • Hospital General de Jaén

    Jaén

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital Xeral Calde

    Lugo

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Clínica Quirón

    Madrid

  • Fundación Jiménez Díaz

    Madrid

  • Hospital Gregorio Marañon

    Madrid

  • Hospital La Paz

    Madrid

  • Hospital de Manresa

    Manresa, Barcelona

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

  • Hospital Son Dureta

    Palma de Mallorca, Mallorca, 07014

  • Hospital Son Llàtzer

    Palma de Mallorca, Mallorca, 07198

  • Hospital de Sagunto

    Sagunto, Valencia

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Clínico de Santiago

    Santiago de Compostela

  • Hospital General de Segovia

    Segovia

  • Hospital Mútua de Terrassa

    Terrassa, Barcelona

  • Hospital Arnau de Vilanova

    Valencia, 46015

  • Hospital General Universitario

    Valencia

  • Hospital La Fe

    Valencia

  • Hospital Xeral Cies

    Vigo, 36024

  • Hospital de Meixoeiro

    Vigo, 36200

  • Hospital Provincial de Zamora

    Zamora, 49021

  • Hospital Clínico Lozano Blesa

    Zaragoza

  • Hospital Miguel Servet

    Zaragoza

Other trials in Spain

About this study

Official title: Open Label Randomized, Multi-centre Phase III Trial of TPF Plus Concomitant Treatment With Cisplatin and Radiotherapy Versus Concomitant Cetuximab and Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.

An Open Label Randomized, Multi-Centre Phase III Trial of TPF Chemotherapy Plus Concomitant Treatment With Cisplatin and Conventional Radiotherapy Versus TPF Chemotherapy Plus Concomitant Cetuximab and Conventional Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.

Read the detailed description

This study is being sponsored by a cooperative medical group.

Being tested
TPF, radiotherapy and cisplatin., TPF, radiotherapy and cetuximab.
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 cisplatin.Other

    Also called TPF plus radiotherapy and cisplatin

    3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy, divided into daily doses of 2 Gray (total days: 35) Cisplatin: 100 mg/m2, i.v., 1 hour, 3 days

  • TPF, radiotherapy and cetuximab.Other

    Also called TPF plus radiotherapy and cetuximab

    3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 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

Study groups in NCT00716391
Study groupRoleWhat they receive
Group AActive comparatorTPF plus concomitant treatment with cisplatin and conventional radiotherapy.
Receives: Other: TPF, radiotherapy and cisplatin.
Group BExperimentalTPF plus concomitant treatment with cetuximab and conventional radiotherapy
Receives: Other: TPF, radiotherapy and cetuximab.

What is being measured

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

  1. Global survival

    The time from the start of induction chemotherapy with TPF to death due to any cause or to the last check-up in the case of living patients

    Measured: Up to 89 months

Secondary outcomes (4)

  1. Overall response rate (ORR)

    The response rate (CR + PR) measured using the RECIST 1.0 method.

    Measured: Up to 89 months

  2. Progression free-survival (PFS)

    Time to progression as the time since the start date of treatment with TPF induction chemotherapy until the time when DP occurred or death occurred due to any cause.

    Measured: Up to 89 months

  3. Time to loco-regional control of disease

    As permanent and complete resolution of the disease in terms of its initial site and lymph nodes (T and N). If the disease lasted (regardless of size), the tumor recurred, or a second tumor appeared in the field RT, it will be recorded as a therapeutic failure.

    Measured: Up to 89 months

  4. Satisfaction with treatment. Analysis of QoL in both treatment arms.

    EORTC QoL questionnaires: C30 version 3.0 and QLQ-H\&N35 module

    Measured: Up to 89 months

Timeline

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

  1. First posted16 Jul 2008 (estimated)
  2. Study start7 Jul 2008
  3. Primary completion18 Jul 2017
  4. Study completionDec 2017

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
519 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00716391
Sponsor's protocol ID
TTCC-2007-01
Status last verified
May 2019
First submitted
14 Jul 2008
Last updated
24 May 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TPF, radiotherapy and cisplatin. and TPF, radiotherapy and cetuximab. in people with Head and Neck Cancer, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 39 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 17 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: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Global survival (time frame: Up to 89 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 NCT00716391.

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 24 May 2019.

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