Prospective, multicentre phase II study of de-escalation of primary chemoradiotherapy of squamous cell carcinoma of oropharynx (OPC) associated with human papilloma virus (HPV)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517832-23-00

Acronym

NADEJ201901

Enrollment

100

Registered

2024-11-04

Start date

2020-01-09

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus oropharyngeal squamous cell carcinoma

Brief summary

Two-year locoregional control

Detailed description

Primary loco-regional control after initial intervention and CRT, Overall survival, Disease-specific survival, Survival without disease, Percentage of distant metastases, Adverse effects, Influencing QoL, Reliability and validity of biomarker p16, Difference in OPC-associated HPV molecular profile in non-smokers and smokers

Interventions

DRUGCISPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Two-year locoregional control	—

Secondary

Measure	Time frame
Primary loco-regional control after initial intervention and CRT, Overall survival, Disease-specific survival, Survival without disease, Percentage of distant metastases, Adverse effects, Influencing QoL, Reliability and validity of biomarker p16, Difference in OPC-associated HPV molecular profile in non-smokers and smokers	—

Countries

Slovakia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026