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

August 18, 2021 updated by: Prof. Esther Troost, Technische Universität Dresden
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of acute and intermediate radiation induced side effects
Time Frame: no later than six months after end of treatment
no later than six months after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

German Cancer Research Center
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (ESTIMATE)

April 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STR - PRONTOX - 2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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