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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00941135
Recruitment Status : Terminated
First Posted : July 17, 2009
Last Update Posted : September 29, 2011
Salutis Research, SL
Unidad de Genética Clínica (Clínica Universitaria de Navarra)
Information provided by (Responsible Party):
Fundacion Miguel Servet

Brief 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.

Condition or disease Intervention/treatment Phase
Laryngeal Neoplasms Other: Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2009
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab

    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

    Other Name: TPF (Chemotherapy Regimen code)

Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00941135

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Hospital Carlos Haya
Malaga, Andalucía, Spain, 29010
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Fundación Jiménez Díaz
Madrid, Spain, 28040
Sponsors and Collaborators
Fundacion Miguel Servet
Salutis Research, SL
Unidad de Genética Clínica (Clínica Universitaria de Navarra)
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Principal Investigator: Fernando Arias, MD Hospital de Navarra
Principal Investigator: Ruth Vera, MD Hospital de Navarra
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Responsible Party: Fundacion Miguel Servet Identifier: NCT00941135    
Other Study ID Numbers: HN2008
EudraCT number: 2008-003365-29
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological