Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone for Patients With Oligo-metastatic Stage IV Non-small Cell Lung Cancer (NSCLC).
18 Years
N/A
Both
Stage IV (Oligo-metastases), Non-small Cell Lung Cancer
Trial Information
Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone for Patients With Oligo-metastatic Stage IV Non-small Cell Lung Cancer (NSCLC).
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.
Inclusion Criteria:
- Histological or cytological proven NSCLC
- UICC stage IV, or solitary metastases (< 5), which are amendable for radical local
treatment
- Performance status 0-2
- Other malignancy is allowed if controlled at the point of diagnosis
Exclusion Criteria:
- Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
- Stage I-III, except for T4 because of pleural metastases
- Performance status 3 or more
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Overall survival
Outcome Description:
The survival of participating patient two years after entering the study
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Dirk De Ruysscher, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
MAASTRO clinic, Maastricht Radiation Oncology
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
Oligometa's
NCT ID:
NCT01282450
Start Date:
May 2006
Completion Date:
July 2011
Related Keywords:
- Stage IV (Oligo-metastases)
- Non-Small Cell Lung Cancer
- Radiotherapy
- NSCLC
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasm Metastasis
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