NCT02731001

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

5.3 years

First QC Date

April 1, 2016

Last Update Submit

August 18, 2021

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Occurrence of acute and intermediate radiation induced side effects

    no later than six months after end of treatment

Study Arms (2)

Proton therapy

EXPERIMENTAL

Patients within the proton arm will receive 66 Gy(RBE) delivered with 6 fractions per week.

Radiation: Proton therapy

Photon therapy

ACTIVE COMPARATOR

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

Interventions

Proton therapyRADIATION
Proton therapy
Photon therapyRADIATION
Photon therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiotherapy and Radiation Oncology

Dresden, 01307, Germany

RECRUITING

Related Publications (1)

  • Zschaeck S, Simon M, Lock S, Troost EG, Stutzer K, Wohlfahrt P, Appold S, Makocki S, Butof R, Richter C, Baumann M, Krause M. PRONTOX - proton therapy to reduce acute normal tissue toxicity in locally advanced non-small-cell lung carcinomas (NSCLC): study protocol for a randomised controlled trial. Trials. 2016 Nov 15;17(1):543. doi: 10.1186/s13063-016-1679-4.

    PMID: 27846903DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Esther Troost, Prof.

    Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf

    STUDY CHAIR

Central Study Contacts

Esther Troost, Prof.

CONTACT

+49 351 458 2238str.studien@uniklinikum-dresden.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Esther Troost

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 7, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2025

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)