Non-small Cell Lung Cancer Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Netherlands | MAASTRO clinic | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | The survival of participating patient two years after entering the study | 2 years | No |
Primary | Overall survival | The survival of participating patients, three years after entering the study. | 3 years | No |
Secondary | Progression free survival | 2 years | No | |
Secondary | Dyspnea (CTC4.0) | 2 years | No | |
Secondary | Dysphagia (CTC 4.0) | 2 years | No | |
Secondary | Patterns of recurrence | 2 years | No | |
Secondary | Progression free survival | 3 years | No | |
Secondary | Dyspnea (CTC4.0) | 3 years | No | |
Secondary | Dysphagia (CTC4.0) | 3 years | No | |
Secondary | Patterns of recurrence | 3 years | No |
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