NCT02607397

Brief Summary

The cost of particle therapy (PT) are considerably higher than conventional radiotherapy (RT) with photons. Considering potential dosimetric advantages of PT, it is necessary to determine if PT are more cost-effective than photons per indication regarding quality of life, survival, and progression free survival. Given the lack of evidence for the benefit of particle therapy in relevant cases, investigators proposed an in silico trial to investigate to what extend proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. Given validated dose-response curves and/or NTCP models, a 10% lower mean dose of proton therapy on normal tissue compared to photon therapy should result in at least a 20% lower risk of side effects.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Geographic Reach
2 countries

4 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

November 12, 2015

Last Update Submit

March 27, 2017

Conditions

Low Grade Glioma

Outcome Measures

Primary Outcomes (2)

  • Dmean

    The normal tissue dose volume parameters per tumor type are defined as Hippocampus: Dmean

    1 month

  • Dmax

    The normal tissue dose volume parameters per tumor type are defined as Hippocampus: Dmax

    1 month

Secondary Outcomes (1)

  • Normal Tissue Complication Probability

    1 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

25 patients. Each patient will function as his or her own control.

You may qualify if:

  • Low Grade Glioma patients
  • Treated with radical intent

You may not qualify if:

  • No Low Grade Glioma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Heidelberg

Heidelberg, Germany

Location

University Hospital Giessen and Marburg

Marburg, Germany

Location

Radiotherapy Group

Deventer, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, Netherlands

Location

Study Officials

  • Philippe Lambin, MD, PhD

    Maastro Clinic, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 18, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

DE(2)NL(2)