To assess tumor reponse with FDG-PET-CT imaging early after start of concomitant chemo-radiotherapy in relation to cytological, histological and biological tumor characteristics. The ultimate goal is to reveal more insight in tumor reponse assesment…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Early response assesment during treatment with concomitant chemo-radiotherapy
for stage III lung cancer with FDG-PET-CT imaging and biological tumor
characteristics.
Secondary outcome
Survival, progression-free survival, toxicity.
Background summary
Patients with stage III lung cancer are mostly treated with a combination of
chemotherapy and radiotherapy. This toxic treatment leads to survival only in a
minority of patients. Intensification of treatment schedules for example by
concomitant chemoradiotherapy leads to some improvement of survival.
Unfortunately this is also accompagnied by increased toxicity. In selected
cases survival can be improved by surgery after induction chemo-radiotherapy
treatment: only in case of down-staging and Ro resection and if pneumonectomie
can be avoided. Assays are needed that can predict tumor response early during
treatment to select patients who are responders and will benefit from the
treatment and minimize side effects for the non-responders with early
modulation of treatment.
Research in other forms of cancer has shown that PET imaging is a usefull tool
in recognizing responders and non-responders early during treatment and that a
PET guided algorithm can be used in the treatment of cancer patients to
modulate therapy.
Study objective
To assess tumor reponse with FDG-PET-CT imaging early after start of
concomitant chemo-radiotherapy in relation to cytological, histological and
biological tumor characteristics. The ultimate goal is to reveal more insight
in tumor reponse assesment and recognizing responders and and non-responders to
concomitant chemo-radiotherapy for stage III lung cancer.
Study design
This is a non-randomized single-centre open label study.
Study burden and risks
Patients included are diagnosed and treated according to normal local
standards. For the study they will be subjected to an extra FDG-PET-CT and an
extra invasive procedure and an extra bloodsample will be taken on the routine
moments for venapunction during this treatment schedule. Patients cannot use a
meal prior to these extra investigational procedures. The extra exposure to one
extra PET-CT is very low when compared to radiotherapy treatment. The extent of
the burden of these extra procedures can be justified by the rationale of this
study. Study results are expected to give more insight in tumor response
assesment and in recognition of responders and non-responders. We hope this
will justify a PET-decision making study in the future to test our hypothesis
that tumor response can be assesed shortly after start of treatment leading to
an early selection of patients who will benefit of the treatment and patients
whom an unnescecarry toxic treatment can be withheld.
geert groteplein 8
6500 HB Nijmegen
NL
geert groteplein 8
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
stage III with cytologically or histologically proven N2 or N3 disease or T4 patients who are to be treated with concomitant chemoradiotherapy
age 18-70
performance status ECOG 0-1
no contraindications for chemo-radiotherapy, surgery or diagnostic procedures
Exclusion criteria
pregnancy
previous radiotherapy to the chest
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 | NL20237.091.08 |