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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01941303

Enrollment

Registered

2013-09-13

Start date

2014-08-31

Completion date

2015-09-30

Last updated

2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer

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.

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 The ones available on re-irradiation with curative intent used outdated techniques \[Okamoto 2002, Wu 2003\].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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival	1 year after radiotherapy	Checking patients for progression
Overall survival	1 year after radiotherapy	Measuring survival by checking if patients are alive.
Locoregional control	1 year after radiotherapy	Measuring locoregional control by checking pt for progression

Secondary

Measure	Time frame	Description
Pulmonary toxicity	1 year after radiotherapy	Checking patients for pulmonary adverse events
Oesophageal toxicity	1 year after radiotherapy	Checking patients for oesophageal adverse events
Other dose-limiting or burdensome toxicity	1 year after radiotherapy	Checking patients fortoxicity which causes problems with regard to radiotherapy-dose or is otherwise burdensome

Countries

Netherlands

Outcome results