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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02731001
Recruitment Status : Recruiting
First Posted : April 7, 2016
Last Update Posted : September 14, 2017
German Cancer Research Center
National Center for Radiation Research in Oncology Dresden/Heidelberg
Information provided by (Responsible Party):
Prof. Esther Troost, Technische Universität Dresden

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Radiation: Proton therapy Radiation: Photon therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer
Study Start Date : August 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Proton therapy
Patients within the proton arm will receive 66 Gy(RBE) delivered with 6 fractions per week.
Radiation: Proton therapy
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.
Radiation: Photon therapy

Primary Outcome Measures :
  1. Occurrence of acute and intermediate radiation induced side effects [ Time Frame: no later than six months after end of treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02731001

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Contact: Esther Troost, Prof. +49 351 458 2238

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Department of Radiotherapy and Radiation Oncology Recruiting
Dresden, Germany, 01307
Contact: Esther Troost, Prof.    +49 351 458 2238   
Sponsors and Collaborators
Technische Universität Dresden
German Cancer Research Center
National Center for Radiation Research in Oncology Dresden/Heidelberg
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Study Chair: Esther Troost, Prof. Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Esther Troost, Technische Universität Dresden Identifier: NCT02731001    
Other Study ID Numbers: STR - PRONTOX - 2014
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms