The objective of the present study is to investigate whether a metabolic response as assessed by 18F-FDG PET can be observed after the first fraction of SBRT. This study will contribute to establishing the role of definitive SBRT in the treatment of…
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The metabolic response after the first fraction
Secondary outcome
1. The metabolic response 12 weeks after completion of SBRT
2. The intra-individual dynamics between these scans
3. Tumor response on CT-thorax according to RECIST-criteria 12 weeks after
completion of SBRT
Background summary
Lobectomy is considered treatment of choice for stage I/II NSCLC [28]. Non
surgical treatments are offered to medically inoperable patients or those who
refuse surgery. Conventionally fractionated radiotherapy is frequently offered
to this selected patient population, however, it results in poor local control
and overall survival rates. Stereotactic body radiotherapy (SBRT) is a
relatively new approach in the treatment of NSCLC. This technique utilizes
precise radiation delivery, enabling the delivery of biological doses > 100 Gy,
in 3-8 fractions. It results in local control rates comparable to those
obtained with surgery. Therefore, SBRT has become standard treatment for
patients with stage I-II NSCLC.
At the moment tumour response is assessed 12 weeks after SBRT. A
CT-thorax is used to measure size, and an 18F-FDG PET scan is used to evaluate
the *metabolic response* of the tumour. An early metabolic response, i.e. the
metabolic response already during treatment, has shown to select patients with
different outcomes. Whether an early response occurs during SBRT for NSCLC is
unknown, and is subject of the present study.
Study objective
The objective of the present study is to investigate whether a metabolic
response as assessed by 18F-FDG PET can be observed after the first fraction of
SBRT. This study will contribute to establishing the role of definitive SBRT
in the treatment of stage I/II NSCLC.
Study design
Observational pilot study
Study burden and risks
To administer 18F-FDG, patients will receive an IV catheter. This may result in
local tenderness and bruising afterwards.
The radiation dose of a single 18F-FDG PET scan has been calculated at 7 mSv.
Thus, the extra radiation dose received for the purpose of this study is 7 mSv.
This dose is negligible when compared to the radiotherapy dose given (i.e.
approximately 60.000 mSv). Although the comparison between absorbed local
irradiation (SBRT) and total body irradiation (18F-FDG PET scan) is difficult,
we assume that the extra radiation of the 18F-FDG PET scan is not hazardous for
the patients.
Postbus 30.001
9700 RB Groningen
Nederland
Postbus 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
T1-T3, N0, M0
Adequate pulmonary function
Medically inoperable or refused surgery
Life expectancy of at least 6 months
Histological conformation of non-small cell lung cancer or a F-FDG positive, growing mass on CT-thorax, suggestive of NSCLC
Exclusion criteria
Disease other than T1-T3, N0 M0
Inadequate pulmonary function
Life expectancy less than 6 months
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 | NL20140.042.07 |