Status:
TERMINATED
Cetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer
Lead Sponsor:
Azienda USL 4 Prato
Collaborating Sponsors:
Università degli Studi di Brescia
Conditions:
Head and Neck Neoplasms
Laryngeal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
BACKGROUND: Concomitant radiotherapy and cisplatin (CDDP) based chemotherapy is the standard treatment for LA-NHSCC. This combined modality treatment is linked with considerable acute local and syste...
Detailed Description
PRIMARY OBJECTIVES: Evaluation and comparison of the compliance of the two treatments; SECONDARY OBJECTIVES: Evaluation and comparison of the grade and incidence of acute toxicity; Evaluation and c...
Eligibility Criteria
Inclusion
- Histologically confirmed squamous cell carcinoma (with biopsy on the primary and / or lymph node metastases) of the oral cavity, oropharynx, hypopharynx, larynx supraglottix;
- Locally advanced disease, defined by one of the following criteria: any T, N +, M0 (excluding T1, N1), T3-4, N0, M0;
- Not cancer nasopharynx or paranasal sinuses or salivary glands;
- General conditions and associated diseases which does not allow to perform chemotherapy or radiotherapy in a radical view;
- No other surgical treatments, chemotherapy or radiotherapy for cancer of head and neck or elsewhere, except non-melanoma skin cancer or in situ cervical cancer and other solid tumors for which radical treatment has been completed \> three years prior to enrollment in the study and for which the patient has remained continuously free of disease;
- Accessibility to follow-up;
- Signing of informed consent;
- Interval between examinations of local staging and randomization, maximum 3 weeks
- Interval between randomization and initiation of treatment, maximum 2 weeks
Exclusion
- Age \<18 years
- ECOG performance status \> 0-1
- Hemoglobin \<9 g / dL
- Counts of granulocytes, total \<1.5 x 10 \^ 9 / L
- Platelet count \<100 x 10 \^ 9 / L
- Bilirubin\> 1.5 times upper limit of normal (ULN)
- AST or ALT\> 3 times ULN
- Creatinine clearance \> 50 mL/min
- Mg \> 0.5 mmol/L
- Pregnancy or lactation
- Presence of allergy to study drug or to the excipients used in their formulation
- Peripheral neuropathy ≥ grade 2 (CTCAE v3.0)
- Hearing loss / tinnitus ≥ grade 3 (CTCAE v3.0)
- One of the following conditions:
- Myocardial infarction within 12 months prior to randomization
- Severe congestive heart failure
- Unstable angina
- Cardiomyopathy in act
- Ventricular arrhythmia
- uncontrolled hypertension
- Severe psychotic disorders in act
- Severe infection in act
- Any other serious illness that could interfere with the administration of the therapy provided by the protocol
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01216020
Start Date
October 1 2010
End Date
May 20 2015
Last Update
January 17 2018
Active Locations (7)
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1
Radiotherapy Dept., Arezzo Hospital
Arezzo, Italy
2
Radiotherapy Dept., Brescia University and Medical Oncology Dept., Brescia Hospital
Brescia, Italy, 25100
3
Radiotherapy Dept., Florence University
Florence, Italy, 50100
4
Radiotherapy Dept., Genoa University
Genoa, Italy