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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941303
• Other study ID #: Irradiation treatment outcome
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: March 21, 2016
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• 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 The ones available on re-irradiation with curative intent used outdated techniques [Okamoto 2002, Wu 2003].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: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
Netherlands	MAASTRO clinic	Maastricht	Limburg

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	Measuring survival by checking if patients are alive.	1 year after radiotherapy	No
Primary	Locoregional control	Measuring locoregional control by checking pt for progression	1 year after radiotherapy	No
Primary	Progression-free survival	Checking patients for progression	1 year after radiotherapy	No
Secondary	Pulmonary toxicity	Checking patients for pulmonary adverse events	1 year after radiotherapy	Yes
Secondary	Oesophageal toxicity	Checking patients for oesophageal adverse events	1 year after radiotherapy	No
Secondary	Other dose-limiting or burdensome toxicity	Checking patients fortoxicity which causes problems with regard to radiotherapy-dose or is otherwise burdensome	1 year after radiotherapy	No