PET Response During Chemoradiation of Lung Cancer
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ClinicalTrials.gov Identifier: NCT02315053 |
Recruitment Status :
Completed
First Posted : December 11, 2014
Last Update Posted : October 27, 2017
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Condition or disease | Intervention/treatment | Phase |
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NSCLC | Other: Low dose FDG PET/CT 5 x. | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Dynamic FDG-PET/CT Response During Chemoradiation for NSCLC |
Actual Study Start Date : | March 21, 2013 |
Actual Primary Completion Date : | September 2017 |
Actual Study Completion Date : | September 2017 |

Arm | Intervention/treatment |
---|---|
Low dose FDG PET/CT 5x
Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT).
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Other: Low dose FDG PET/CT 5 x.
Multiple FDG PET/CT studies will be added to the normal diagnostic procedures as a part of this study, with the number of scans depending on the study stage, to a maximum of 6 per patient.
Other Name: No treatment intervention but diagnostic intervention. |
- maximum FDG uptake (SUVmax) [ Time Frame: 1 Year ]• A main study parameter is the maximum FDG uptake (SUVmax (maximum Standardized Uptake Value)) at the location of the primary tumour, as determined at multiple days during treatment (with a maximum of five time points per patient), expressed as T50 for response evaluation.
- SUVmax during the first two weeks of treatment, indicating inflammatory response. [ Time Frame: First Two weeks of treatment ]• Increase SUVmax during the first two weeks of treatment, indicating inflammatory response.
- SUVmax in the two weeks prior to treatment, indicating progression [ Time Frame: Two weeks prior to treatment ]• Increase SUVmax between diagnostic imaging and start of treatment, indicating potential progression.
- Progression free survival [ Time Frame: 1 Year ]• Secondary study endpoint is progression free survival, to be associated with T50 for prognostic value.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 (Fludeoxyglucose) PET/CT
- WHO performance 0-1
- Written informed consent according to GCP (Good Clinical Practice) and national regulations
Exclusion Criteria:
- Age < 18 years, incapacitated subjects
- Pregnant or lactating women
- Diabetes mellitus requiring medication
- Participation in dose escalation studies
- Other neoplasms in the last 3 years, with metastases

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315053
Netherlands | |
The Netherlands Cancer Institute | |
Amsterdam, Noord Holland, Netherlands, 1066CX |
Principal Investigator: | Wouter Vogel, MD,PhD | NKI |
Responsible Party: | The Netherlands Cancer Institute |
ClinicalTrials.gov Identifier: | NCT02315053 |
Other Study ID Numbers: |
N12LPR |
First Posted: | December 11, 2014 Key Record Dates |
Last Update Posted: | October 27, 2017 |
Last Verified: | October 2017 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
NSCLC CCRT FDG PET/CT |