ImmunotherApy for the Prevention of High-Risk Oral DIsorders malignanT transformation - APHRODITE trial

Conditions

Oral disorders

Brief summary

Best overall response rate (CR + PR rate) at 6 months, as defined by the percent change in clinical-pathologic composite score

Detailed description

• Evaluate 3 years and overall malignant transformation rate • Measure drug-induced adverse events and any treatment interruption due to toxicities • Evaluate the change of histological grading of OPMD (based on the World Health Organization WHO classification), • Assess patient reported outcomes, measured via PRO CTCAE at treatment start, at 6 months and then every three months for the following 18 months. Questionnaire will be derived by the NCI- PRO-CTCAE ITEMS-ITALIAN • To assess impact on patients’ quality of life, measured via EORTC QLQC30-HN43, Exploratory Endpoints • Correlate selected biomarkers in tissue and saliva with malignancy-free survival. • Assess narrow-band imaging (NBI) changes during the study treatment and follow up, • To evaluate the LOH status (to be considered positive in patients carrying OPMD with LOH at 3p14 and/or 9p21 plus at least at one additional chromosomal site (4q, 8p,11p,13q, or 17p) or in patients carrying OPMD with a prior oral cancer history and LOH at 3p14 and/or 9p21 (LOH defined according to EPOC trial) at baseline, at 6 months, and in case of malignant transformation.

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Best overall response rate (CR + PR rate) at 6 months, as defined by the percent change in clinical-pathologic composite score	—

Secondary

Measure	Time frame
• Evaluate 3 years and overall malignant transformation rate • Measure drug-induced adverse events and any treatment interruption due to toxicities • Evaluate the change of histological grading of OPMD (based on the World Health Organization WHO classification), • Assess patient reported outcomes, measured via PRO CTCAE at treatment start, at 6 months and then every three months for the following 18 months. Questionnaire will be derived by the NCI- PRO-CTCAE ITEMS-ITALIAN • To assess impact on patients’ quality of life, measured via EORTC QLQC30-HN43, Exploratory Endpoints • Correlate selected biomarkers in tissue and saliva with malignancy-free survival. • Assess narrow-band imaging (NBI) changes during the study treatment and follow up, • To evaluate the LOH status (to be considered positive in patients carrying OPMD with LOH at 3p14 and/or 9p21 plus at least at one additional chromosomal site (4q, 8p,11p,13q, or 17p) or in patients carrying OPMD with a prior oral cancer his	—

Measure

Time frame

• Evaluate 3 years and overall malignant transformation rate • Measure drug-induced adverse events and any treatment interruption due to toxicities • Evaluate the change of histological grading of OPMD (based on the World Health Organization WHO classification), • Assess patient reported outcomes, measured via PRO CTCAE at treatment start, at 6 months and then every three months for the following 18 months. Questionnaire will be derived by the NCI- PRO-CTCAE ITEMS-ITALIAN • To assess impact on patients’ quality of life, measured via EORTC QLQC30-HN43, Exploratory Endpoints • Correlate selected biomarkers in tissue and saliva with malignancy-free survival. • Assess narrow-band imaging (NBI) changes during the study treatment and follow up, • To evaluate the LOH status (to be considered positive in patients carrying OPMD with LOH at 3p14 and/or 9p21 plus at least at one additional chromosomal site (4q, 8p,11p,13q, or 17p) or in patients carrying OPMD with a prior oral cancer his

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Countries

Italy

Outcome results