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Open Label Randomized Phase II, Multicentre, Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Concomitant-Boost Accelerated Radiotherapy Followed or Not by a Complementary Treatment With Cetuximab in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Oropharyngeal Neoplasms

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Trial Information

Open Label Randomized Phase II, Multicentre, Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Concomitant-Boost Accelerated Radiotherapy Followed or Not by a Complementary Treatment With Cetuximab in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.


- To determine the 1-year rate of locoregional disease control in the experimental arm,
using a control arm to avoid selection bias.

- To determine the 2 and 3 year rate of locoregional disease control.

- To evaluate the safety and toxicity of the combination of cetuximab and
concomitant-boost accelerated radiotherapy followed by 12 weeks of complementary
treatment with cetuximab. Both acute and chronic toxicity will be assessed.

- To determine specific disease-free survival, event-free survival, disease-specific
survival and overall survival

- To determine acute and late toxicity

- To determine EGFR, p53, Ki67, and evaluate its value as a prognostic factor.


Inclusion Criteria:



- Written informed consent.

- Aged between 18 and 80, inclusive.

- Karnofsky functional status >= 70% at the time of enrolment in study.

- Life expectancy of more than 3 months.

- Histologically confirmed diagnosis of oropharyngeal squamous cell carcinoma: base of
tongue, vallecula, tonsil and tonsillar fossa and pillars, glossotonsillar sulcus,
inferior surface of the soft palate, uvula and lateral and posterior oropharyngeal
wall.

- Stage III or IV with no evidence of distant metastasis (IVA or IV B)

- Patients in medical conditions to receive a radical concomitant-boost accelerated
radiotherapy treatment.

- Neutrophils >= 1500/ mm3, platelet count >= 100 000/ mm3 and haemoglobin >= 10 g/ dL.

- Proper liver function: total bilirubin <= 1.5 x upper limit of normal (ULN);
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN.

- Proper renal function: serum creatinine <= 1.5 x ULN; if the values are > 1.5 x ULN,
creatinine clearance should be >= 55 ml/min.

- Serum calcium within normal limits.

- Adequate nutritional state: weight loss < 20% with respect to usual weight and serum
albumin > 35 g/l.

- Effective birth control method if there is possibility of conception and/or
pregnancy.

- Availability of tumour tissue for immunohistochemical analysis of EGFR expression.

Exclusion Criteria:

- Metastatic disease.

- Previous surgical, radiotherapy and/or chemotherapy treatment for the disease in the
study.

- Other non-oropharyngeal tumour sites in the head and neck area.

- Other previous and/or simultaneous squamous cell carcinoma.

- Diagnosis of any other cancer in the previous 5 years, except properly treated
carcinoma in situ of the uterine cervix and/or basal cell skin carcinoma.

- Active infection (infection requiring intravenous antibiotics), including active
tuberculosis and diagnosed HIV.

- Uncontrolled hypertension defined as systolic blood pressure >= 180 mm Hg and/or
diastolic blood pressure >= 130 mm Hg at rest.

- Pregnancy (absence of pregnancy must be confirmed with the serum-HCG test) or
breast-feeding women.

- Chronic, concomitant systemic immunotherapy, or hormonal treatment for the cancer.

- Other concomitant anti-cancer treatments.

- Clinically significant coronary artery disease, history of myocardial infarction in
the previous 12 months or high risk of out of control arrhythmia or cardiac
insufficiency.

- Chronic obstructive pulmonary disease which may have required > 3 hospitalisations in
the previous 12 months.

- Out of control active peptic ulcer.

- Presence of a psychological or medical illness which might impede the patient from
carrying out the study or giving his or her signature on the informed consent

- Known drug abuse (with the exception of excessive alcohol consumption)

- Known allergic reaction to any of the components of the treatment to be studied.

- Previous treatment with monoclonal antibodies or signal transduction inhibitors or
other EGFR-targeted treatment.

- Any experimental treatment in the 30 days prior to enrolment in the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1-year rate of Locoregional Disease Control in the experimental arm, deffined as complete and persistent disappearance of disease in the primary tumour and regional lymph nodes.

Principal Investigator

Ricard Mesia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Catala Oncologia: Hospital DurĂ¡n y Reynals

Authority:

Spain: Spanish Agency of Medicines

Study ID:

62202-655

NCT ID:

NCT00251381

Start Date:

November 2005

Completion Date:

November 2009

Related Keywords:

  • Oropharyngeal Neoplasms
  • Oropharyngeal Neoplasms
  • Cetuximab
  • Concomitant-boost accelerated radiotherapy
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Oropharyngeal Neoplasms

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