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

Phase 2

Terminated

• Conditions: Laryngeal Neoplasms

• Registration Number: NCT00941135
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-28
• Last Update Posted: 2011-09-29
• Primary Completion: 2013-05
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (4)

Hospital Carlos Haya; 🇪🇸 Malaga, Andalucía, Spain

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain