To determine whether SRT achieves a local control rate comparable to surgery in patients with metastatic lung disease.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Local control
Secondary outcome
To determine whether treatment related toxicity is acceptable (maximal toxicity
grade I-III).
To determine prognostic factors on local control, overall survival and
progression free survival.
Background summary
Local treatment of metastases limited to a few sites could prolong life and
potentially be curable. Five-year overall survival rates of 33-58% have been
reported in patients with limited metastases. Although surgery is the treatment
modality of choice, few patients are suitable candidates due to comorbid
disease or insufficient pulmonary reserve. For these patients stereotactic body
radiation therapy (SRT) may prove beneficial.
SRT is widely used for treatment of early-stage NSCLC and is currently
carefully extended to patients with oligometastases. Okunieff achieved a local
control of 91% after 3 years in patients with a maximum of 5 metastatic lesions
and disease limited to the thorax. No grade 4-5 toxicity was reported in this
series of 125 treated metastatic lesions. Although these results are promising,
experience with SRT in patients with oligometastases is still limited and
further investigation is warranted.
Study objective
To determine whether SRT achieves a local control rate comparable to surgery in
patients with metastatic lung disease.
Study design
Non-randomized, single center prospective phase II trail
Intervention
Patients will be treated with 3-7 fractions of stereotactic radiotherapy
depending on the tumor location. Prior to treatment fiducials will be placed
using one of the following methods: bronchoscopy, percutaneous intra- or
extra-pulmonary placement or intravascular placement. These fiducials are
required for the cyberknife to *track* the tumor, enabling a high radiation
dose to be delivered to a limited lung volume.
Study burden and risks
The sole invasive procedures in the study are the placement of fiducials and
the administration of intravenous contrast for CT-scan imaging. The risk for
complications is greatest after percutaneous intrapulmonal fiducial placement,
reporting a 10-28% incidence of pneumothorax. This risk will be minimized by
careful patient selection for one of the three fiducial placement techniques.
During the study duration of maximum three years, a total of 12 visits to the
outpatient clinic are planned. In addition to the imaging required for
treatment planning, during the follow up an extra CT-scan is planned at nine
months for treatment evaluation. Exposure to radiation from this diagnostic
imaging is low compared to treatment dose delivered.
Postbus 5201
3008 AE Rotterdam
NL
Postbus 5201
3008 AE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
The patient is eighteen years or older.
The metastases are limited to a maximum of 2 organs, and one of the 2 is the lung.
The patient has no more than 5 metastatic lesions.
The primary tumor site is locally controlled.
The interval between treatment of the primary tumor and diagnosis of the metastasis is at least four months.
The patient has a life expectancy of at least 6 months.
Exclusion criteria
Patients with more than 5 metastatic lesions.
Patients with an active primary tumor site.
pregnant women.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23450.078.08 |