Status:
TERMINATED
Safety and Efficacy Study in Patients With Local Advanced Larynx/Hypolarynx Carcinoma Treated With TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab
Lead Sponsor:
Fundacion Miguel Servet
Collaborating Sponsors:
Salutis Research, SL
Unidad de Genética Clínica (Clínica Universitaria de Navarra)
Conditions:
Laryngeal Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00941135
Start Date
May 1 2009
End Date
May 1 2013
Last Update
September 29 2011
Active Locations (4)
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1
Hospital Carlos Haya
Málaga, Andalusia, Spain, 29010
2
Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
3
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain, 31008
4
Hospital de Navarra
Pamplona, Navarre, Spain, 31008