NCT02908386

Brief Summary

Given the lack of evidence for the benefit of particle therapy in relevant cases, he investigators proposed an in silico trial to investigate the dosimetric effect of contour changes for OAR as well as tumor during chemoradiation in H\&N patients. Photon and proton-therapy will be compared based on dosimetric data on 7 time points during treatment combined with plan robustness. In that way the investigators will be able to assess and compare the optimal timing for replanning for photon and proton therapy. A database of the University of Pennsylvania (Upenn) consists of 10 patients with head and neck tumors treated with chemo-radiation. Contrast-enhanced CT scans were acquired prior and during RT (T1-T7)

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

April 13, 2016

Last Update Submit

September 16, 2016

Conditions

Head and Neck Neoplasms

Keywords

Head and neck tumorsProtonPhotonreplanning timing

Outcome Measures

Primary Outcomes (1)

  • Dose distribution

    Dose values of seven time frames (T1-T7) are compared to the reference dose values on the planning CT for both photon and proton treatment plans.

    up to 26 weeks

Secondary Outcomes (1)

  • Optimal timing for replanning

    up to 26 weeks

Other Outcomes (1)

  • Plan uncertainties and robustness

    up to 26 weeks

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of 10 consecutive patients treated with proton therapy at the University of Pennsylvania (USA). Other treatment modalities for the tumor sites, such as chemotherapy will not be taken into account. Included are H\&N patients who have been treated with radical intent. Each patient will function as his or her own control.

You may qualify if:

  • patients with head and neck carcinoma who have been treated with radical intent 10 patients, all with a reference CT scan and CT scans at 7 time points during treatment.

You may not qualify if:

  • patients with no head and neck cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • Roelofs E, Engelsman M, Rasch C, Persoon L, Qamhiyeh S, de Ruysscher D, Verhaegen F, Pijls-Johannesma M, Lambin P; ROCOCO Consortium. Results of a multicentric in silico clinical trial (ROCOCO): comparing radiotherapy with photons and protons for non-small cell lung cancer. J Thorac Oncol. 2012 Jan;7(1):165-76. doi: 10.1097/JTO.0b013e31823529fc.

    PMID: 22071782RESULT

  • Barker JL Jr, Garden AS, Ang KK, O'Daniel JC, Wang H, Court LE, Morrison WH, Rosenthal DI, Chao KS, Tucker SL, Mohan R, Dong L. Quantification of volumetric and geometric changes occurring during fractionated radiotherapy for head-and-neck cancer using an integrated CT/linear accelerator system. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):960-70. doi: 10.1016/j.ijrobp.2003.12.024.

    PMID: 15234029RESULT

  • Ricchetti F, Wu B, McNutt T, Wong J, Forastiere A, Marur S, Starmer H, Sanguineti G. Volumetric change of selected organs at risk during IMRT for oropharyngeal cancer. Int J Radiat Oncol Biol Phys. 2011 May 1;80(1):161-8. doi: 10.1016/j.ijrobp.2010.01.071. Epub 2010 Nov 19.

    PMID: 21306971RESULT

  • Geets X, Tomsej M, Lee JA, Duprez T, Coche E, Cosnard G, Lonneux M, Gregoire V. Adaptive biological image-guided IMRT with anatomic and functional imaging in pharyngo-laryngeal tumors: impact on target volume delineation and dose distribution using helical tomotherapy. Radiother Oncol. 2007 Oct;85(1):105-15. doi: 10.1016/j.radonc.2007.05.010. Epub 2007 Jun 11.

    PMID: 17562346RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Philippe Lambin, Prof dr

    Maastro Clinic, The Netherlands

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

April 13, 2016

First Posted

September 21, 2016

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

November 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Locations

US(1)