Sancuso

80% of Head and neck cancer (HNC) are diagnosed at a locally/advanced stage. The treatment for locally/advanced HNC is mainly based on surgery combined with adjuvant (chemo)radiotherapy or definitive (chemo)radiotherapy. The combined dose with radiotherapy of cisplatin is 70 mg/m2 every 3 weeks, for a total of 3 cycles. Patients receiving cisplatin chemotherapy with concurrent radiotherapy are at risk of significant nausea. Moreover, the adverse effects of the above treatment combination (sticky saliva, oral infections, dysgeusia) frequently observed after the 4th week of radiotherapy tend to worsen patient’s nausea. A complete protection starting from the second cycle is reported to yield symptom control in about 5% of the patients treated with cisplatin and radiotherapy for HNC during the whole period between the 2nd and the 3rd chemotherapy cycle. The SANCUSO study is a phase 2, single arm, open label trial, in which patients will receive the antiemetic therapy based on ESMO-MASCC guidelines during the 1st chemotherapy cycle, coincident with the first week of radiation. As of the 4th week of chemo-radiotherapy treatment, patients will be administered Granisetron trasnsdermal patch for the control of nausea and vomiting. The patients will use Granisetron trasnsdermal patch every week, and receive the remaining standard antiemetic therapy, with Dexamethasone and neurokinin inhibitor – NK1) when cisplatin is administered.

Main selection criteria are:
– Diagnosis of head and neck cancer in one of the following subsites: oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, paranasal sinus, salivary gland, skin of the head and neck, unknown primary in head and neck area;
– Patients naive to chemotherapy;
– Patients planned to receive 3 cycles of highly emetogenic treatment with cisplatin in single dose > 70 mg/m2 every 21 days concomitant with IMRT on head and neck;
– Presence of brain metastasis are not allowed;
– Patients scheduled to receive or have received in the past 4 weeks radiation treatment to brain, abdomen, or pelvis;
– Patients with presence of significant nausea within 24 hours before the first chemotherapy cycle are not allowed;
– Planned surgery procedures in the period of the study or within 2 weeks after the study conclusion are not allowed;
– Patients with a history of seizures are not allowed

The primary objective of the SANCUSO trial is to evaluate the activity of the Sancuso patch in controlling nausea and vomiting in terms of proportion of patients with complete control of nausea (defined as the absence of vomiting, no rescue treatment, and no significant nausea) during the entire period of chemoradiation (starting from 4th week of chemotherapy until 1 week after radiotherapy end). The secondary objectives are to assess the safety of study drug, to evaluate the compliance of study drug, to study impact on health related quality of life (MDASI-HN questionnaire) and on patients reported outcomes (PRO-CTCAE) and to develop a validated library for measuring symptoms burden in HNC undergoing chemo-radiotherapy.