Clinical trial · Interventional
Cetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient recruitment
Summary
Brief summary (as posted)
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)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Laryngeal Neoplasms | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
| Pharyngeal Neoplasms | Pharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- cetuximab plus radiotherapy
- description
- 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).
- interventionNames
- Drug: cetuximab
- type
- ACTIVE_COMPARATOR
- label
- cisplatin plus radiotherapy
- description
- CDDP 40 mg/mq in a single weekly 1-hour infusion concomitant to radiotherapy: (70 Gy to clinically involved sites)
- interventionNames
- Drug: cisplatin (associated to radiotherapy)
Primary outcomes (1)
- measure
- Compliance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBuglione M, Maddalo M, Corvo R, Pirtoli L, Paiar F, Lastrucci L, Stefanacci M, Belgioia L, Crociani M, Vecchio S, Bonomo P, Bertocci S, Borghetti P, Pasinetti N, Triggiani L, Costa L, Tonoli S, Grisanti S, Magrini SM. Subgroup Analysis According to Human Papillomavirus Status and Tumor Site of a Randomized Phase II Trial Comparing Cetuximab and Cisplatin Combined With Radiation Therapy for Locally Advanced Head and Neck Cancer. Int J Radiat Oncol Biol Phys. 2017 Mar 1;97(3):462-472. doi: 10.1016/j.ijrobp.2016.10.011. Epub 2016 Oct 20. PMID 27986347