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Clinical Trials > Head and Neck

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DAHANCA-21 Hyperbaric oxygen treatment of mandibular osteoradionecrosis.

HOPON HOPON: Hyperbaric Oxygen for the Prevention of Osteoradionecrosis.

One complication of radiotherapy for head and neck cancer is osteoradionecrosis (ORN) of the jaws. Osteoradionecrosis (ORN) describes the process where irradiated bone undergoes necrosis and becomes exposed through the investing soft tissues for a period of at least 3 months. The most important risk factor for ORN is surgical trauma, commonly dental extractions in an irradiated jaw, but ORN can also occur spontaneously. ORN is painful and debilitating, sometimes requiring surgical resection of the jaw and/or hyperbaric oxygen (HBO) treatments. The morbidity and mortality of osteoradionecrosis is significant and treatment outcomes often unsatisfactory.
REALISTIC A Phase I, Dose Escalation Trial Of Recombinant Listeria Monocytogenes (Lm)-Based Vaccine Encoding Human Papilloma Virus Serotype 16 Target Antigens (ADXS11-001) In Patients With HPV-16 +ve Oropharyngeal Carcinoma

HPVs are obligate human pathogens, some have the propensity to promote malignant transformations of their host cells. An example of this is HPV-16 in the oropharyngeal squamous cell carcinoma, which is seen in about 50-70% of cases although there is geographical variation.

ADXS11-001 (formerly Lovaxin C) is a bioengineered strain of living Listeria monocytogenes that induces a strong therapeutic immune response using multiple mechanisms of action. This vaccine secretes the tumour antigen HPV-16 E7 fused to an attenuated Lm virulence factor, Listeriolysin O (LLO), which has strong adjuvant properties.

If proved safe, there is a role for ADXS11-001 as a post-treatment adjuvant as part of a treatment de-escalation strategy in an attempt to reduce the adverse effects of current treatment strategies without compromising survival. The REALISTIC trials' objective is to determine safety and to characterise the toxicity profile of ADXS11-001.
TITAN Trial of Induction TPF Therapy in Advanced Head & Neck Cancer.

TITAN is a open-label randomized controlled trial conducted in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC).

Induction(TPF) chemotherapy is a significant recent advance in the management of locally advanced HNSCC, although its use in combination with surgery and postoperative radiotherapy(PORT) is under-researched.

TITAN address the potential survival advantage of TPF induction chemotherapy prior to surgery and radiotherapy for locally advanced resectable SCCHN.

All recruitment and site information is updated hourly from LCTU systems