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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Proton therapy
Photon therapy
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Radiotherapy and Radiation OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Proton therapy

Photon therapy

Arm Description

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

Patients within the photon arm will be treated by intensity modulated radiotherapy with 6 fractions per week to a total dose of 66 Gy.

Outcomes

Primary Outcome Measures

Occurrence of acute and intermediate radiation induced side effects

Secondary Outcome Measures

Full Information

First Posted
April 1, 2016
Last Updated
August 18, 2021
Sponsor
Technische Universität Dresden
Collaborators
German Cancer Research Center, National Center for Radiation Research in Oncology Dresden/Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT02731001
Brief Title
Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer
Acronym
PRONTOX
Official Title
Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technische Universität Dresden
Collaborators
German Cancer Research Center, National Center for Radiation Research in Oncology Dresden/Heidelberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proton therapy
Arm Type
Experimental
Arm Description
Patients within the proton arm will receive 66 Gy(RBE) delivered with 6 fractions per week.
Arm Title
Photon therapy
Arm Type
Active Comparator
Arm Description
Patients within the photon arm will be treated by intensity modulated radiotherapy with 6 fractions per week to a total dose of 66 Gy.
Intervention Type
Radiation
Intervention Name(s)
Proton therapy
Intervention Type
Radiation
Intervention Name(s)
Photon therapy
Primary Outcome Measure Information:
Title
Occurrence of acute and intermediate radiation induced side effects
Time Frame
no later than six months after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Troost, Prof.
Phone
+49 351 458 2238
Email
str.studien@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Troost, Prof.
Organizational Affiliation
Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Radiotherapy and Radiation Oncology
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Troost, Prof.
Phone
+49 351 458 2238
Email
str.studien@uniklinikum-dresden.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27846903
Citation
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.
Results Reference
derived

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

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