Clinical trial NCT01941303: Analysis of Treatment Outcome and Toxicity in Non-small Cell Lung Cancer Patients Wither-irradiated to a High Dose for Recurrent Disease
Official title: Radical Re-irradiation of Recurrent NSCLC - Analysis of Outcome and Toxicity.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer undergoing chest irradiation (with chemotherapy) to a radical dose twice: in the primary and the recurrent setting.

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 The ones available on re-irradiation with curative intent used outdated techniques \[Okamoto 2002, Wu 2003\].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

Eligibility 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.

Primary outcomes:
measure: Overall survival
timeFrame: 1 year after radiotherapy
measure: Locoregional control
timeFrame: 1 year after radiotherapy
measure: Progression-free survival
timeFrame: 1 year after radiotherapy
Secondary outcomes:
measure: Pulmonary toxicity
timeFrame: 1 year after radiotherapy
measure: Oesophageal toxicity
timeFrame: 1 year after radiotherapy
measure: Other dose-limiting or burdensome toxicity
timeFrame: 1 year after radiotherapy
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
state: Limburg
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Esther Troost, PhD
role: PRINCIPAL_INVESTIGATOR
References: