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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Laryngeal Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Fernando Arias, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital de Navarra

Authority:

Spain: Ethics Committee

Study ID:

HN2008

NCT ID:

NCT00941135

Start Date:

May 2009

Completion Date:

May 2013

Related Keywords:

  • Laryngeal Neoplasms
  • Neoplasms
  • Carcinoma
  • Laryngeal Neoplasms

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