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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2025
  • participants needed
    98
  • sponsor
    Technische Universität Dresden
Updated on 23 February 2022
metastasis
lung carcinoma

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.

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.

Details
Condition Non-Small Cell Lung Cancer
Treatment proton therapy, Photon therapy
Clinical Study IdentifierNCT02731001
SponsorTechnische Universität Dresden
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Participation in other interventional trial
T1 or T2 N0 tumours that are candidates for stereotactic radiotherapy
relevant neurological or psychiatric disorders that hinder treatment, follow-up or understanding of the procedures
pregnant or breastfeeding women
prior thoracic radiotherapy
history of other malignancies during the last 5 years (exceptions can be made for tumours with excellent outcome)
weight loss greater than 15% before therapy
serological alterations (liver, kidney) prohibiting application of simultaneous chemotherapy
respiratory motion of the tumour > 10 mm (evaluated by 4D CT), also when methods for motion reduction (abdominal compression) are used
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