NCT01504815

Adaptive Radiation Treatment for Head and Neck Cancer

Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This Phase III trial aims to: Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN. The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area. To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	cisplatinum	i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
RADIATION	Conventional radiotherapy	conventional radiotherapy, 70Gy in 7 weeks
RADIATION	Adaptive radiotherapy	adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks

Timeline

• Start date: 2012-09-07
• Primary completion: 2021-12-01
• Completion: 2024-12-24
• First posted: 2012-01-05
• Last updated: 2025-01-29

Locations

9 sites across 5 countries: France, Netherlands, Spain, Sweden, United Kingdom