General objective:• Determine the prognostic value of T50 for treatment outcome of CCRT for NSCLC.Secondary objectives:• S1: Confirm the image quality of extremely low dose FDG PET/CT scans.• S1: Test the complex study logistic with all involved…
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• The main study parameter is the maximum FDG uptake (SUVmax) at the location
of the primary tumour, as determined at multiple days during treatment (up to
five time points per patient), expressed as T50 for response evaluation.
• The main study endpoint is progression free survival, to be correlated with
T50 for prognostic value.
Secondary outcome
Secondary study parameters/endpoints
• Increase SUVmax during de first two weeks of treatment, indicating
inflammatory response.
• Increase SUVmax between diagnostic imaging and day 1, indicating potential
progression.
Other study parameters
Available image sets will be evaluated using several other diagnostic methods.
This will not contribute to the main study outcome, but may yield interesting
additional knowledge and potential new strategies for outcome prediction.
• Anatomical response based on RECIST criteria.
• Biological response based on EORTC criteria.
• Alternative T50 based on SUVmean of the primary tumour.
• Alternative T50 based on SUVpeak of the primary tumour.
• Alternative T50 based on SUVmax/mean of nodal metastases in the imaging range.
• Voxel-based evaluation to identify intra-tumoural differences in response.
Background summary
The treatment of inoperable non-small cell lung cancer (NSCLC) is radiotherapy
with concurrent chemotherapy, 24 fractions of 2.75 Gy (66Gy) combined with
concurrent Cisplatin 6 mg/m2. However with curative intent, only a small
percentage will survive. This study aims to determine the optimal time point to
measure response during CCRT as a base to change treatment.
Study objective
General objective:
• Determine the prognostic value of T50 for treatment outcome of CCRT for NSCLC.
Secondary objectives:
• S1: Confirm the image quality of extremely low dose FDG PET/CT scans.
• S1: Test the complex study logistic with all involved departments (nuclear
medicine, outpatient clinic, radiotherapy).
• S2: Determine the shape of the FDG response curve during CCRT for NSCLC.
• S2: Determine occurrence and timing of an early inflammatory response to CCRT.
• S2: Determine the variation between the SUVmax at diagnostic PET/CT and day 1
of treatment.
• S2: Determine the distribution in time of T50 in the specified patient group.
• S2: Define an optimal measurement strategy for T50 during CCRT.
• S3: Determine the prognostic value of T50 with regard to local and regional
control.
Study design
In Stage 1 of the study, 2 pilot patients will undergo 1 extra PET/CT scan, the
first to confirm the image quality of extremely low dose FDG scans and
the second to test the complex study logistic with all involved departments.
In the second stage to a maximum of 40 patients, five FDG PET/CT scans during
treatment and one for follow up will be added to the normal diagnostic
procedures as a part of this study. Changes in the SUVmax will be measured, to
determine the FDG response curve, inflammation peak, and mean T50.
Providing a succesful result of Stage 2, about another 40 patients in Stage 3
will undergo less than 6 scans to correlate the T50 with progression free
survival, to determine the prognostic value. For this third Stage an amendment
will then be written and started after permission of the PTC of the NKI-AVL.
Also an amendement for the ABR form will be made.
Study burden and risks
No is expected from the FDG injections or the PET/CT scans (however a small
amount of radiation dose will be given).
The logistical burden for the patients is 6 hours fasting plus 1.5 hour extra
in the NKI-AVL on all days of PET imaging.
No additional IV access is needed. All FDG, saline and Cisplatin can be
administered using the same IV cannula, that would already be placed for
standard CCRT or follow up CT-scan. The time in the hospital will be as short
as possible by giving the saline of the outpatient clinic during FDG
biodistribution.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
• Cytologically or histologically proven NSCLC
• T2-4 N0-3 M0 disease (stage II or III, inoperable)
• Scheduled for standard concurrent chemoradiation
• Primary tumour minimal diameter 3 cm
• Primary tumour SUVmax > 5 on routine diagnostic pre-treatment FDG PET/CT
• WHO performance 0-1
• Written informed consent according to GCP and national regulations
Exclusion criteria
• Age < 18 years
• Incapacitated subjects
• Pregnant or lactating women
• Diabetes Mellitus
• Participation in dose escalation studies
• Other neoplasms with metastases in the last 3 years
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 | NL39209.031.12 |