Analysis of Treatment Outcome and Toxicity in Non-small Cell Lung Cancer Patients Wither-irradiated to a High Dose for Recurrent Disease

NCT ID: NCT01941303

Last Updated: 2016-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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 The ones available on re-irradiation with curative intent used outdated techniques \[Okamoto 2002, Wu 2003\].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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Advanced stage non-small cell lung cancer patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht Radiation Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Troost, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastro Clinic, The Netherlands

Locations

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MAASTRO clinic

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Irradiation treatment outcome

Identifier Type: -

Identifier Source: org_study_id

NCT01930825

Identifier Type: -

Identifier Source: nct_alias

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