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

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.
 
ClinicalTrials.gov Identifier: NCT00765011
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: TPF, radiotherapy and cetuximab Procedure: H&N surgery Phase 2

Detailed Description:
This study is being sponsored by a cooperative medical group.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : October 2008
Actual Primary Completion Date : February 2014
Actual Study Completion Date : May 12, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
TPF plus concomitant treatment with cetuximab and conventional radiotherapy
 Drug: TPF, 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
Other Name: TPF plus radiotherapy and cetuximab
Grupo B
Surgery
 Procedure: H&N surgery
Rescue surgery
Other Name: Rescue surgery


Outcome Measures
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Primary Outcome Measures :
  1. Specific survival free of total laryngectomy [ Time Frame: Three years after the end of treatment with radiotherapy and cetuximab ]
    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.


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form.
  2. Men or women, age (18 and 70).
  3. ECOG scale:0-1.
  4. Life expectancy superior to 3 months.
  5. Larynx squamous carcinoma histologically demonstrated.
  6. 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.
  7. Patients to be able to receive treatment with TPF followed by normofractionated radiotherapy with cetuximab.
  8. Measurable disease (OMS criteria).
  9. Neutrophils superior or equal to 1500/mm3, platelets superior or equal to 150.000/mm3, hemoglobin superior or equal to 10 g/dl.
  10. Adequate renal function: creatinin lower or equal to 120 µmol/l (1,4mg/dl)
  11. 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.
  12. Seric calcium adjusted to albumine lower or equal to 1,25 UNL.
  13. Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.
  14. Use of an effective contraceptive method.

Exclusion Criteria:

  1. Metastatic disease
  2. Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.
  3. Other tumour locations in H&N that are not larynx.
  4. Other stages that are not III or IVa without metastasis and resectable disease.

  5. The following cases, which will be considered candidates for radical surgery, will not be included in the study:

    • Tumors of the subglottis.
    • 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).
  6. Other previous and/or synchronic squamous carcinoma.
  7. Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.
  8. Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.
  9. 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.
  10. Pregnancy or breastfeeding.
  11. Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.
  12. Other antineoplasic concomitant treatments.
  13. 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.
  14. Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months.
  15. Active non controlled peptic ulcer.
  16. 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.
  17. Known drugs abuse (excepting excessive consumption of alcohol).
  18. Known allergic reaction to some of the components of the treatment of the study.
  19. Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR.
  20. Any experimental treatment in 30 days before entry in the study.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00765011


Locations
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Sponsors and Collaborators
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Investigators
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Principal Investigator: Ricard Mesía Nin, MD Hospital Durán i Reynals
Principal Investigator: José A. García Sáenz, MD Hospital San Carlos, Madrid
More Information
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Additional Information:

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Responsible Party: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
ClinicalTrials.gov Identifier: NCT00765011    
Other Study ID Numbers: TTCC-2007-02
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Keywords provided by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello:
Head and Neck Cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Laryngeal Neoplasms
Neoplasms by Site
Neoplasms
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
 Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents