ClinicalTrials.gov processed this data on March 27, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00765011TTCC-2007-02NCT00765011TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx CancerA 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 TPFGrupo Español de Tratamiento de Tumores de Cabeza y CuelloOtherNo
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.
This study is being sponsored by a cooperative medical group.
CompletedOctober 2008May 12, 2015February 2014Phase 2InterventionalNoNon-RandomizedSingle Group AssignmentPreventionNone (Open Label)Specific survival free of total laryngectomyThree years after the end of treatment with radiotherapy and cetuximabTime 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.294Head and Neck CancerGroup AExperimentalTPF plus concomitant treatment with cetuximab and conventional radiotherapyGrupo BOtherSurgeryDrugTPF, radiotherapy and cetuximab3 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 daysGroup ATPF plus radiotherapy and cetuximabProcedureH&N surgeryRescue surgeryGrupo BRescue surgery
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.
All18 Years70 YearsNoRicard Mesía Nin, MDPrincipal InvestigatorHospital Durán i ReynalsJosé A. García Sáenz, MDPrincipal InvestigatorHospital San Carlos, MadridHospital Germans Trias i PujolBadalonaBarcelona08916SpainHospital Duran i ReynalsL'Hospitalet de LlobregatBarcelonaSpainHospital de ManresaManresaBarcelonaSpainHospital Clínic i Provincial de BarcelonaBarcelona08036SpainHospital San Pedro de AlcántaraCáceresSpainHospital Dr.Josep Trueta (ICO Girona)Girona17007SpainHospital Universitario Virgen de las NievesGranadaSpainOncogranadaGranadaSpainHospital Xeral CaldeLugoSpainHospital Gregorio MarañonMadridSpainHospital Universitario 12 de OctubreMadridSpainHospital Universitario San CarlosMadridSpainHospital Son LlátzerPalma De MallorcaSpainHospital Universitario de SalamancaSalamancaSpainHospital Universitario la Fe de ValenciaValenciaSpainHospital Clínico Universitario de ZaragozaZaragozaSpainHospital Miguel ServetZaragozaSpainSpainhttp://www.ttccgrupo.orgThis site would like to expose the activities of the group and at the same time serve as an information and communication tool of this pathology for professionals and patients.April 2019October 1, 2008October 1, 2008October 2, 2008April 9, 2019April 9, 2019April 11, 2019SponsorHead and Neck CancerHead and Neck NeoplasmsLaryngeal NeoplasmsCetuximab