To investigate the dynamics of tumour hypoxia as assessed by 18F-FAZA PET/CT during and after chemoradiotherapy. To investigate the best strategy to deliver a boost dose to the hypoxic tumour areas. This strategy may be either a simultaneous boost (…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessing tumour hypoxia using 18F-FAZA-PET/CT for stage III NSCLC during
curative chemoradiotherapy
Secondary outcome
To investigate tumour heterogeneity with respect to metabolism (18F-FDG-PET)
and hypoxia (18F-FAZA-PET)
Correlation between 18F-FAZA-PET/CT identified tumour hypoxic areas and
18F-FDG-PET/CT metabolically active areas
To investigate metabolic response as assessed by 18F-FDG-PET/CT during
treatment
To investigate hypoxia response as assessed by 18F-FAZA-PET/CT during treatment
Background summary
Lung cancer is the leading cause of worldwide cancer mortality. Non-small cell
lung carcinoma (NSCLC) accounts for 80% of all cases, of which approximately
30% is stage III disease. Chemoradiotherapy is the cornerstone in the
management of locally advanced NSCLC. Unfortunately, loco-regional control
remains poor with 5-years overall survival rates of about 15-25%. An important
contributor of poor local control after radiotherapy is tumour hypoxia.
This study aims to investigate the best treatment strategy to deliver high
radiation dose precisely to hypoxic zones with sophisticated imaging
techniques like PET/CT using specific biological tracers such as FAZA.
Performing FAZA-PET/CT scans during chemoradiotherapy can give valuable
information about the dynamics of tumour hypoxia during treatment thereby
adjust radiotherapy treatment planning to improve local tumour control and
overall survival.
Study objective
To investigate the dynamics of tumour hypoxia as assessed by 18F-FAZA PET/CT
during and after chemoradiotherapy.
To investigate the best strategy to deliver a boost dose to the hypoxic tumour
areas. This strategy may be either a simultaneous boost (SIB) technique to
escalate the dose to hypoxic areas, in the case of stable hypoxic areas during
treatment, or a single stereotactic boost dose to the hypoxic area in the case
of fluctuating hypoxic areas.
Finally, the relation between tumour hypoxia and tumour metabolism during
chemoradiotherapy will be investigated.
Study design
Observational pilot study
Study burden and risks
Patients will receive 4 extra FAZA-PET/CT (24mSv) and 2 extra FDG-PET/CT
(15.2mSv) overall patients receive 39.2mSv.
This extra radiation dose exposure is considered acceptable in relation to the
prescribed radiation dose (60.000mSv).
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- WHO PS 0-2
- Histological or cytological confirmation of non-small cell lung cancer.
- Stage IIIA or IIIB
- Adequate pulmonary function estimated by flow volume curves
- Life expectancy of at least 6 months
- Planned for 25 x 2.4 Gy 3DCRT, with concomitant chemotherapy
Exclusion criteria
- Other stages than stage III NSCLC
- PS > 2
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 | NL33218.042.10 |