Head and Neck Neoplasms Clinical Trial
— CTXMAB+RTOfficial title:
Multiinstitutional Open Label Randomized Phase II Study Comparing Cetuximab and Radiotherapy Versus Cisplatin and Radiotherapy as Firstline Treatment for Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-NHSCC)
Verified date | January 2018 |
Source | Azienda USL 4 Prato |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
systemic toxicity.EGFR is overexpressed in 90-100% of the HNSCC cases and is considered an
unfavourable prognostic marker. EGFR costitutive activation is linked with HNSCC
pathogenesis.
Cetuximab is a monoclonal anti-EGFR antibody blocking the activation of the receptor and
signal transduction. Cetuximab combined with radiotherapy is superior to radiotherapy only in
the treatment of LA-HNSCC and is characterized by an acceptable toxicity profile.
RATIONALE:
A direct comparison between concomitant chemoradiotherapy with Cisplatin and the concomitant
treatment with radiotherapy associated to cetuximab does not exist.
STUDY DESIGN:
Arm A: Radical radiotherapy (doses and volumes) concomitant with chemotherapy with Cisplatin
(40 mg/mq/week) Arm B: Radical radiotherapy (doses and volumes) concomitant with therapy with
the monoclonal antibody Cetuximab (400 mg/m2 ["loading dose"] and subsequently 250 mg
/m2/week)
Status | Terminated |
Enrollment | 70 |
Est. completion date | May 20, 2015 |
Est. primary completion date | May 20, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Radiotherapy Dept., Arezzo Hospital | Arezzo | |
Italy | Radiotherapy Dept., Brescia University and Medical Oncology Dept., Brescia Hospital | Brescia | |
Italy | Radiotherapy Dept., Florence University | Firenze | |
Italy | Radiotherapy Dept., Genoa University | Genoa | |
Italy | Radiotherapy Dept., Azienda USL 4 Prato | Prato | |
Italy | Radiotherapy Dept., Siena University | Siena | |
Italy | Radiotherapy Dept., Turin University | Torino |
Lead Sponsor | Collaborator |
---|---|
Azienda USL 4 Prato | Università degli Studi di Brescia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compliance | Evaluation and comparison of the compliance of the two treatments arms | weekly during treatment | |
Secondary | event free survival | Evaluation and comparison of the event free survival (both local control and distant metastases) | bimonthly for two years, every 6 months thereafter | |
Secondary | acute toxicity | Evaluation and comparison of the grade and incidence of acute toxicity. | Weekly during treatment. | |
Secondary | Local control | Evaluation and comparison of local control | bimonthly for two years after treatment, every six months thereafter | |
Secondary | cause specific survival | Evualation and comparison of cause specific survival | bimonthly after treatment for two years, then every 6 months | |
Secondary | overall survival | evaluation and comperison of overall survival | bimonthly after treatment for two years, then every 6 months |
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