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Completed

NCT Number: NCT01941303

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

MAASTRO clinic

Maastricht, Limburg, 6229 ET, Netherlands

About this study

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 The ones available on re-irradiation with curative intent used outdated techniques [Okamoto 2002, Wu 2003].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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 1 year after radiotherapy

    Measuring survival by checking if patients are alive.

  2. Locoregional control

    Time frame: 1 year after radiotherapy

    Measuring locoregional control by checking pt for progression

  3. Progression-free survival

    Time frame: 1 year after radiotherapy

    Checking patients for progression

Secondary outcomes

  1. Pulmonary toxicity

    Time frame: 1 year after radiotherapy

    Checking patients for pulmonary adverse events

  2. Oesophageal toxicity

    Time frame: 1 year after radiotherapy

    Checking patients for oesophageal adverse events

  3. Other dose-limiting or burdensome toxicity

    Time frame: 1 year after radiotherapy

    Checking patients fortoxicity which causes problems with regard to radiotherapy-dose or is otherwise burdensome

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Official study title

Radical Re-irradiation of Recurrent NSCLC - Analysis of Outcome and Toxicity.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 13, 2013
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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