CompletedPhase 3

Definitive Chemo-Radiotherapy for Regionally Advanced Head and Neck Cancer With or Without Up-front Neck Dissection

Switzerland65 participantsStarted 2016-12-16

Plain-language summary

Treatment of regionally-advanced head and neck squamous cell carcinoma (HNSCC) requires a multidisciplinary approach with a combination of surgery, radiotherapy (RT) and chemotherapy. Due to these aggressive combined modalities, patients undergoing treatment and many survivors develop toxicities which impact quality of life (QoL) and sometimes lead to mortality. Lymph node metastases of HNSCC are frequent and considered one of the most important prognostic factors, resulting in decreased survival by 50%. More than three decades, the optimal management strategy of node positive HNSCC was a key subject of debate. In summary, the current literature provides us two important findings: First, with the contemporary imaging and treatment modalities, there is no role of a planned neck dissection (ND) added to (chemo)radiotherapy ((C)RT) in terms of oncological outcome and survival. Second, with modern RT techniques, a tailored treatment followed after an up-front neck dissection (UFND) allows a significant reduction of treatment volumes and de-escalation of the dose to the neck, leading to reduction of treatment related toxicities. In this study strategies with and without up-front neck dissection prior to chemo-radiotherapy will be compared.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓2. No allergy to study drugs or to the excipients in their formulation.
✓3. No peripheral neuropathy ≥grade 2 according to CTCAE v4.03 (grade 2 = moderate symptoms limiting instrumental ADL)
✓4. No co-existing disease prejudicing survival (expected survival \<6 months).
✓5. No severe cardiac illness: Myocardial infarction within 6 months prior to randomization, severe congestive heart failure, severe cardiomyopathy, ventricular arrhythmia, unstable angina, uncontrolled hypertension.
✓6. No active bacterial or fungal infection requiring intravenous antibiotics at the time of registration
✓7. No Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 28 days before registration.
✓8. No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
✓9. No clinically manifested Acquired Immune Deficiency Syndrome (AIDS) or immune-compromised patients. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

What they're measuring

Number of patients with acute & subacute toxicity based on CTCAE scoring system v4.03

Timeframe: from the beginning of radiotherapy until 90 days after the end of the treatment

Trial details

NCT IDNCT02918955

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-24

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