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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01930825
Other study ID # Treatment outcome NSCLC
Secondary ID
Status Completed
Phase N/A
First received August 26, 2013
Last updated April 7, 2014
Start date February 2013
Est. completion date March 2014

Study information

Verified date April 2014
Source Maastricht Radiation Oncology
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial 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.


Description:

MAASTRO clinic is a leader in the (individual) management of patients with lung cancer. This has resulted in major publications in the past on individualized (chemo)radiotherapy for (NSCLC) [van Baardwijk 2006 and 2010]. 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 is also given in curative intent, thus again using high doses of radiation.

Publications on this topic are rare. Most reports address the results of palliative re-irradiation of NSCLC [Ebara 2007, Jackson 1987, Montebello 1993, Tada 2005]. The ones available on re-irradiation with curative intent used outdated techniques [Okamoto 2002, Wu 2003]. Only one recent publication has analyzed the results of 37 NSCLC patients of whom 9 were re-irradiated with at least 50 Gy using helical tomotherapy [Kruser in press].

The results of radical re-irradiation applying highly conformal radiation techniques within MAASTRO are unknown. This study will provide knowledge on benefit and risks of such a therapeutic approach. Furthermore, it may provide enough evidence to initiate a Phase II/III clinical trial for re-irradiation of NSCLC patients with curative intent.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date March 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Advanced stage non-small cell lung cancer

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Analysis
Retrospective analysis of outcome and toxicity

Locations

Country Name City State
Netherlands MAASTRO clinic Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival One year after treatment No
Primary Locoregional control One year after treatment No
Primary Progression-free survival One year after treatment No
Secondary Pulmonary toxicity One year after treatment No
Secondary Oesophageal toxicity One year after treatment No
Secondary Other dose-limiting or burdensome toxicity One year after treatment No
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