drugset / Trial / NCT00169247

Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation

NCT00169247 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Larynx preservation remains a very challenging approach in patients with larynx/pharynx cancer. A first attempt consisted of induction chemotherapy followed in good responders by irradiation. This approach allowed to preserve 60 % of the larynx without any significant difference in survival. The second attempt consisted of concurrent chemo-irradiation. This approach provided a higher larynx preservation rate but survival remained unchanged and mucosal toxicity was also higher. A third approach is currently under evaluation: induction chemotherapy followed by concurrent chemo-irradiation in good responders.

Timeline

Start
2005-10
Primary completion
2011-04
Completion
—

Outcome

Missed primary endpoint

paper In an intent-to-treat analysis, there was no significant difference in LP at 3 months between arms A and B (95% and 93%, respectively) PMID 23341517 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 —
Subject Cisplatin Other / unclassified 100 mg/m2 —