Proton Therapy to Reduce Acute Normal Tissue Toxicity in... | NCT02731001

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

NCT02731001

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

Aug 19, 2021Actual

Enrollment

98Estimated

Phase

Not Applicable

Conditions

Non-Small Cell Lung Cancer

Interventions

Proton therapy
Photon therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Apr 1, 2016

First Submission Date that Met QC Criteria

Apr 1, 2016

First Posted Date

Apr 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2021

Last Update Posted Date

Aug 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Esther Troost, Prof. Esther Troost, Technische Universität DresdenPrincipal Investigator

Lead Sponsor

Technische Universität DresdenOTHER

Collaborators

Name	Class
German Cancer Research Center	OTHER
National Center for Radiation Research in Oncology Dresden/Heidelberg	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Proton therapy	Radiation		Proton therapy
Photon therapy

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Esther Troost, Prof.	Contact	+49 351 458 2238		str.studien@uniklinikum-dresden.de

Overall Officials

Name	Affiliation	Role
Esther Troost, Prof.	Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiotherapy and Radiation Oncology	Recruiting	Dresden		01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27846903	Derived	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.

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

ID	Term
D063193	Heavy Ion Radiotherapy
D011878	Radiotherapy
D013812	Therapeutics