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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT02731001

Studienbeginn:
August 2016

Letztes Update:
19.08.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technische Universität Dresden

Collaborator:
German Cancer Research Center, National Center for Radiation Research in Oncology Dresden/Heidelberg,

Studienleiter

Esther Troost, Prof.
Study Chair
Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf

Kontakt

Esther Troost, Prof.
Kontakt:
Phone: +49 351 458 2238
E-Mail: str.studien@uniklinikum-dresden.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Radiotherapy and Radiation Oncology
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Esther Troost, Prof.
Phone: +49 351 458 2238
E-Mail: str.studien@uniklinikum-dresden.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Occurrence of acute and intermediate radiation induced side effects (Time Frame - no later than six months after end of treatment)

Studien-Arme

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.

Geprüfte Regime

Proton therapy
Photon therapy

Quelle: ClinicalTrials.gov

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