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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• NSCLC (confirmed by cytology or histology) staged UICC IIIA or IIIB or UICC II if the patient declines surgery

• no distant metastases (M1)

• patient' age between 18 and 70 years

• Patient medically suited for primary radiochemotherapy with curative intent

• signed declaration of informed consent

• adequate compliance for treatment and clinical follow up

• adequate contraception during and after therapy if indicated

Locations
Other Locations
Germany
Department of Radiotherapy and Radiation Oncology
RECRUITING
Dresden
Contact Information
Primary
Esther Troost, Prof.
str.studien@uniklinikum-dresden.de
+49 351 458 2238
Time Frame
Start Date: 2016-08
Estimated Completion Date: 2025-12
Participants
Target number of participants: 98
Treatments
Experimental: Proton therapy
Patients within the proton arm will receive 66 Gy(RBE) delivered with 6 fractions per week.
Active_comparator: Photon therapy
Patients within the photon arm will be treated by intensity modulated radiotherapy with 6 fractions per week to a total dose of 66 Gy.
Sponsors
Leads: Technische Universität Dresden
Collaborators: German Cancer Research Center, National Center for Radiation Research in Oncology Dresden/Heidelberg

This content was sourced from clinicaltrials.gov