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

This study is currently recruiting participants.
Verified September 2017 by Prof. Esther Troost, Technische Universität Dresden
Sponsor:
ClinicalTrials.gov Identifier:
NCT02731001
First Posted: April 7, 2016
Last Update Posted: September 14, 2017
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.
Collaborators:
German Cancer Consortium (DKTK)
National Center for Radiation Research in Oncology Dresden/Heidelberg
Information provided by (Responsible Party):
Prof. Esther Troost, Technische Universität Dresden
  Purpose
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 Intervention
Non-Small Cell Lung Cancer Radiation: Proton therapy Radiation: Photon therapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Prof. Esther Troost, Technische Universität Dresden:

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

Estimated Enrollment: 98
Study Start Date: August 2016
Estimated Study Completion Date: October 2024
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02731001


Contacts
Contact: Esther Troost, Prof. +49 351 458 2238 str.studien@uniklinikum-dresden.de

Locations
Germany
Department of Radiotherapy and Radiation Oncology Recruiting
Dresden, Germany, 01307
Contact: Esther Troost, Prof.    +49 351 458 2238    str.studien@uniklinikum-dresden.de   
Sponsors and Collaborators
Technische Universität Dresden
German Cancer Consortium (DKTK)
National Center for Radiation Research in Oncology Dresden/Heidelberg
Investigators
Study Chair: Esther Troost, Prof. Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Esther Troost, Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02731001     History of Changes
Other Study ID Numbers: STR - PRONTOX - 2014
First Submitted: April 1, 2016
First Posted: April 7, 2016
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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms