Analysis of Treatment Outcome and Toxicity in NSCLC Patients Wither-irradiated to a High Dose for Recurrent Disease.

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930825
• Other study ID #: Treatment outcome NSCLC
• 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 The ones available on re-irradiation with curative intent used outdated techniques [Okamoto 2002, Wu 2003].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

• NSCLC

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