NCT02844140

Brief Summary

Dose distribution calculations for proton therapy are more accurate when based on DE-CT than on SE-CT. It is however unclear what the quantitative benefit of repeated DE-CT calculations is for lung cancer patients.

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 Sep 2016

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withdrawn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

First Submitted

Initial submission to the registry

July 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 14, 2017

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

July 19, 2016

Last Update Submit

April 13, 2017

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Dose distribution on the CTV (measured in Gy)

    Dose distribution on the CTV (clinical target volume) of the tumour and the lymph nodes of DE-CT vs. SE-CT

    Measured during 2nd and 4th week of radiation treatment

  • Dose distribution on the OAR (measured in Gy)

    Dose distribution on the OAR (organs at risk), lungs, heart, aorta, pulmonary artery, superior vena cava, oesophagus, spinal cord, vertebral body, of DE-CT vs. SE-CT

    Measured during 2nd and 4th week of radiation treatment

Study Arms (1)

Scans

EXPERIMENTAL

Patients included in the trial will receive DE-CT in stead of SE-CT's.

Procedure: DE-CT's and SE-CT

Interventions

DE-CT's and SE-CTPROCEDURE

Patients included in the trial will receive 3 extra DE-CT's and 3 extra SE-CT's

Scans

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed locally advanced stage IIIA or III B (T0-4 N2-3M0) NSCLC, or M1 oligometastatic disease according to 7th TNM classification.
  • Scheduled to receive concurrent chemotherapy and radiotherapy to a dose of at least 60 Gy, as decided at the multidisciplinary tumour board
  • Able to give written informed consent
  • Able to have adequate contraception in woman with child bearing potential

You may not qualify if:

  • Not able to give written informed consent
  • Not able to comply with adequate contraception in woman with child bearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAASTRO clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dirk De Ruysscher, MD, PhD

    Maastro Clinic, The Netherlands

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 26, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

April 14, 2017

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)