Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone for Patients With Oligo-metastatic Stage IV Non-small Cell Lung Cancer (NSCLC)
|ClinicalTrials.gov Identifier: NCT01282450|
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : July 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Stage IV (Oligo-metastases) Non-small Cell Lung Cancer||Radiation: Radiotherapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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).|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Experimental: Single arm
Other Name: Radiotherapy with or without surgery or chemotherapy
- Overall survival [ Time Frame: 2 years ]The survival of participating patient two years after entering the study
- Overall survival [ Time Frame: 3 years ]The survival of participating patients, three years after entering the study.
- Progression free survival [ Time Frame: 2 years ]
- Dyspnea (CTC4.0) [ Time Frame: 2 years ]
- Dysphagia (CTC 4.0) [ Time Frame: 2 years ]
- Patterns of recurrence [ Time Frame: 2 years ]
- Progression free survival [ Time Frame: 3 years ]
- Dyspnea (CTC4.0) [ Time Frame: 3 years ]
- Dysphagia (CTC4.0) [ Time Frame: 3 years ]
- Patterns of recurrence [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282450
|Maastricht, Limburg, Netherlands, 6229 ET|
|Principal Investigator:||Dirk De Ruysscher, MD, PhD||MAASTRO clinic, Maastricht Radiation Oncology|