Trial intelligence / Profile preview

Radiotherapy Plus Cetuximab vs Chemoradiotherapy in HPV-Associated Oropharynx Cancer

NCT01302834Phase 3

Key facts

Status: Completed
Start: Jun 2011
Primary completion: Jul 2018
Countries: 2
Sponsor: NRG Oncology
Modality: Monoclonal Antibodies

Drugs: KL-140
Conditions: oropharyngeal cancer

Overview

Phase 3, randomised, open-label trial of KL-140 in oropharyngeal cancer (2 arms), sponsored by NRG Oncology. Primary endpoint: Overall Survival at 6.5 years. Started Jun 2011; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

IMRT + Cisplatin
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin
IMRT + Cetuximab
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Who it enrols

Adults with p16-positive, stage T1-2, N2a-N3 or T3-4, any N oropharyngeal squamous cell carcinoma, Zubrod PS 0-1, adequate organ function, no prior systemic therapy or radiotherapy for the study cancer, and no prior anti-EGFR therapy.

Endpoints

Primary

Overall Survival6.5 years

Secondary

Progression-free Survival6.5 years
Time to Local-regional Failure6.5 years
Time to Distant Metastasis6.5 years
Time to Secondary Primary Cancer6.5 years
Adverse Events5 years
EORTC QLQ-C30 Global Health Status12 months
EORTC QLQ-H&N35 Swallowing12 months
EuroQol Five Dimension Scale 3-level Version12 months

Beyond the preview

Go deeper on NCT01302834.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01302834.