NCT01941303

Brief Summary

As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent non-small cell lung cancer. Even after primary radical treatment to high doses, re-irradiation (with concurrent chemotherapy) is also given in curative intent, thus again using high doses of radiation. Publications on high-dose re-irradiation of lung cancer patients are scarce, and outcome and toxicity for patients treated in MAASTRO are unknown at present. This study will provide knowledge on benefit and risks of such a therapeutic approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

1.1 years

First QC Date

September 3, 2013

Last Update Submit

March 21, 2016

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer

Outcome Measures

Primary Outcomes (3)

  • Overall survival

    Measuring survival by checking if patients are alive.

    1 year after radiotherapy

  • Locoregional control

    Measuring locoregional control by checking pt for progression

    1 year after radiotherapy

  • Progression-free survival

    Checking patients for progression

    1 year after radiotherapy

Secondary Outcomes (3)

  • Pulmonary toxicity

    1 year after radiotherapy

  • Oesophageal toxicity

    1 year after radiotherapy

  • Other dose-limiting or burdensome toxicity

    1 year after radiotherapy

Study Arms (1)

Advanced stage non-small cell lung cancer patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non-small cell lung cancer undergoing chest irradiation (with chemotherapy) to a radical dose twice: in the primary and the recurrent setting.

Patients with advanced stage non-small cell lung cancer treated to higher doses of irradiation (i.e. EQD2\>50Gy) twice: in the primary and recurrent setting.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

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

  • Esther Troost, 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

September 3, 2013

First Posted

September 13, 2013

Study Start

August 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

NL(1)