Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone for Patients With Oligo-metastatic Stage IV Non-small Cell Lung Cancer (NSCLC)
In recent years, it has become clear, that also in non-small cell lung cancer (NSCLC), a group of patients with less than 5 distant metastases may experience long-term survival when treated radically to all macroscopic cancer sites. Thus has mostly been established for individuals with so-called solitary brain metastases and to a lesser extend in solitary adrenal gland metastases, but in other metastatic subgroups, the same may be applicable. In a prospective survey in the region of the Integral Cancercentre (IKL), we could identify on a yearly base 30 patients with NSCLC who could theoretically be amendable for radical treatment of all oligo-metastatic locations. We therefore want to perform a prospective study in which patients with less than 4 oligo-metastatic sites from a primary NSCLC will be treated radically with the aim to improve long-term survival. As many discussion points remain, even after thorough discussions with chest physicians, pulmonary surgeons and colleagues from diagnostic disciplines, we decided to go for a pragmatic approach, implying that all macroscopic disease sites should be treated radically, being defined as surgery with a R0 resection or in case of an unforeseen R1 resection, followed by radiotherapy, or radiotherapy to a biological equivalent of at least 60 Gy in 30 daily fractions. In the same patient, one metastatic site may be treated with surgery and another with radical radiotherapy. Systemic treatment was not made mandatory, because it was felt that it's role is unclear in patients with early stage local cancer and with oligo-metastatic disease.
Stage IV (Oligo-metastases)
Non-small Cell Lung Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone for Patients With Oligo-metastatic Stage IV Non-small Cell Lung Cancer (NSCLC).|
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]The survival of participating patient two years after entering the study
- Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]The survival of participating patients, three years after entering the study.
- Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Dyspnea (CTC4.0) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Dysphagia (CTC 4.0) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Patterns of recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Dyspnea (CTC4.0) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Dysphagia (CTC4.0) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Patterns of recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Single arm
Other Name: Radiotherapy with or without surgery or chemotherapy
Eligible patients (see below) will receive radical radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/- 1Gy, irrespective of lung function and/or to all metastatic sites to a minimal biological equivalent of 60Gy in 30 daily fractions. This may be delivered with hypofractionated stereotactic techniques or with other more protracted fractionation regimen.
Both the primary tumor, the regional N1 lymph nodes and the oligo-metastatic site(s) may be treated with surgery, as long as an R0 resection is deemed possible. Systemic treatment is not required, but should be given according to the local extend of the tumor.
Local radiotherapy will be delivered according to the protocol of MAASTRO clinic for that anatomical site.
Other dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax): 66Gy The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282450
|Maastricht, Limburg, Netherlands, 6229 ET|
|Principal Investigator:||Dirk De Ruysscher, MD, PhD||MAASTRO clinic, Maastricht Radiation Oncology|