NCT02731001

Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aims of the study are to reduce acute radiation induced side effects, i.e. pneumonitis and esophagitis grade II or higher by the use of proton therapy compared to photon radiotherapy of equal total dose. Secondary endpoints include evaluation of quality of life, loco-regional control, survival and late radiation induced side effects.

Detailed description

Patients in this trial undergo primary radiochemotherapy for locally advanced NSCLC. As early and intermediate late effects of radiotherapy do not only hamper quality of life but can, in the case of radiation induced pneumonitis, be potentially lethal, a reduction of these side effects is desirable. Patients in this trial are 1:1 randomised to intensity modulated radiotherapy with photons or proton therapy. The primary aim of the study is to show a decrease of pneumonitis and or esophagitis grade 2 or higher by proton therapy. The observed incidence of both these side effects is 39% with photon therapy. The estimated incidence with proton therapy is around 12 %. Simultaneous chemotherapy will be applied to current clinical standards.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Proton therapy
RADIATION	Photon therapy

Timeline

• Start date: 2016-08-01
• Primary completion: 2021-12-01
• Completion: 2025-12-01
• First posted: 2016-04-07
• Last updated: 2021-08-19

Locations

1 site across 1 country: Germany