Cetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer (CTXMAB+RT)
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|ClinicalTrials.gov Identifier: NCT01216020|
Recruitment Status : Terminated (insufficient recruitment)
First Posted : October 7, 2010
Last Update Posted : January 17, 2018
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.
A direct comparison between concomitant chemoradiotherapy with Cisplatin and the concomitant treatment with radiotherapy associated to cetuximab does not exist.
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)
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms Laryngeal Neoplasms Mouth Neoplasms Pharyngeal Neoplasms||Drug: cetuximab Drug: cisplatin (associated to radiotherapy)||Phase 2|
Evaluation and comparison of the compliance of the two treatments;
Evaluation and comparison of the grade and incidence of acute toxicity; Evaluation and comparison of local control; Evaluation and comparison of event free survival (both local control and distant metastases); Evaluation and comparison of cause specific and overall survival.
- Histologically confirmed squamous cell carcinoma (biopsy obtained from the tumor and/or from its lymphnodal metastases) originating from oral cavity, oropharynx, hypopharinx, supraglottic larynx;
- Locally advanced disease, defined by one of the following criteria: every T, N+, M0 ( T1, N1 cases excluded); T3-4, N0, M0;
- Not a nasopharynx, paranasal sinuses, salivary glands tumor;
- General conditions and concomitant diseases not considered a contraindication for chemotherapy or curative radiotherapy;
- No other surgical, chemotherapeutic or radiotherapic treatments for ENT region tumors or for tumors of other anatomical sites (with the exception of non-melanoma cutaneous tumors and of the carcinoma in situ of the uterine cervix and of other solid tumors whose primary treatment has been completed more than 3 years before the accrual in this study and never relapsed since primary treatment (the patient having been since then continuously disease- free);
- Availability for follow-up;
- Signed informed consent;
- An interval of maximum 3 weeks between staging procedures for local disease and randomization
- An interval of maximum 2 weeks between randomization and the onset of the treatment
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||May 20, 2015|
|Actual Study Completion Date :||May 20, 2015|
Experimental: cetuximab plus radiotherapy
Cetuximab given one week before radiotherapy (loading dose, 400 mg/m2) plus weekly (250 mg/m2), concomitant with radiotherapy (7O Gy on clinically involved sites).
Other Name: Erbitux
Active Comparator: cisplatin plus radiotherapy
CDDP 40 mg/mq in a single weekly 1-hour infusion concomitant to radiotherapy: (70 Gy to clinically involved sites)
Drug: cisplatin (associated to radiotherapy)
Other Name: Cisplatin
- Compliance [ Time Frame: weekly during treatment ]Evaluation and comparison of the compliance of the two treatments arms
- event free survival [ Time Frame: bimonthly for two years, every 6 months thereafter ]Evaluation and comparison of the event free survival (both local control and distant metastases)
- acute toxicity [ Time Frame: Weekly during treatment. ]Evaluation and comparison of the grade and incidence of acute toxicity.
- Local control [ Time Frame: bimonthly for two years after treatment, every six months thereafter ]Evaluation and comparison of local control
- cause specific survival [ Time Frame: bimonthly after treatment for two years, then every 6 months ]Evualation and comparison of cause specific survival
- overall survival [ Time Frame: bimonthly after treatment for two years, then every 6 months ]evaluation and comperison of overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216020
|Radiotherapy Dept., Arezzo Hospital|
|Radiotherapy Dept., Brescia University and Medical Oncology Dept., Brescia Hospital|
|Brescia, Italy, 25100|
|Radiotherapy Dept., Florence University|
|Firenze, Italy, 50100|
|Radiotherapy Dept., Genoa University|
|Radiotherapy Dept., Azienda USL 4 Prato|
|Prato, Italy, 59100|
|Radiotherapy Dept., Siena University|
|Radiotherapy Dept., Turin University|
|Study Chair:||Stefano M Magrini, Prof||Radiotherapy Dept., Brescia Hospital and Brescia University|