NSCLCPET BoostNCT01024829
Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using FDG-PET-CT Scan in Stage IB, II and III NSCLC
A study testing Radiotherapy in people with NSCLC, run by The Netherlands Cancer Institute at 7 sites in 5 countries.
Trial summary
Increasing ("boosting") the radiation dose for patients with non-small cell lung carcinoma to the individual maximal dose which can safely be given. The question is if patients should receive this boost on the whole tumor on part of the tumor. Therefore patients are randomized for one of these two treatment options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesin 5 countries
- Study dates
- May 2010to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years with any subtype of pathologically proven (biopsy or cytology), non-small cell lung cancer. The diagnosis may be established from biopsy or cytology obtained from the primary tumor and/ or from metastatic lymph nodes.
- Minimal diameter of the primary tumor 4 cm, this to allow for boosting of sub-volumes.
- UICC TNM Stage T2-4, N0-3, M0 disease (TNM definition see appendix 2).
- Only stage IB-II patients who are nog candidates for surgery are study candidates.
- Measurable disease at registration.
- ECOG-performance status ≤ 2 (see appendix 6)
Show all 16Show fewer
- Lung function: FEV1 and DLCO at least 40 % of the age-adjusted normal value
- Willing and able to give a written informed consent.
- Patients with locoregional recurrent lung tumor following surgery or a second primary cancer (at least 3 years after treatment) are eligible, unless a pneumonectomy was performed.
- SUVmax in the pre-treatment FDG-PET scan ≥ 5 for the primary tumor.
- Adequate organ function, including the following:
- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL.
- Hepatic: bilirubin ≤ 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) ≤ 3.0 x ULN (AP, AST, and ALT ≤ 5 x ULN is acceptable if liver has tumor involvement).
- Renal: calculated creatinine clearance (CrCl) ≥ 45 ml/min based on the original weight based Cockcroft and Gault formula
- For women: Must be surgically sterile, postmenopausal, or compliant with a highly reliable contraceptive method (failure rate <1%) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment and must not be breast-feeding.
- For men: Must during chemotherapy take adequate contraceptive measures.
Who cannot join
- Prior radiotherapy to the thorax.
- Clinical superior vena cava syndrome, malignant pleural effusion or malignant pericardial effusion.
- T4, specified as:Tumor growth in large blood vessels on spiral CT scan or encasement >50%
- multiple nodules in the same or ipsilateral lobe(s).
- Post-obstructive atelectasis or infiltration that cannot be distinguished from tumor on a CT-PET scan.
- Patients with a diagnosis of other cancer within the last 3-years (except in situ carcinoma's and / or non-melanoma skin cancer).
- Pregnant women, lactating women
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Netherlands3 sites
NKI/AVL
Amsterdam, 1066CX
Academic Medical Centre
Amsterdam, 1105AZ
MAASTRO clinic
Maastricht, Limburg, 6229 ET
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: Dose Escalation by Boosting Radiation Dose Within the Primary Tumor on the Basis of a Pre-treatment FDG-PET-CT Scan in Stage IB, II and III NSCLC: a Randomized Phase II Trial
Increasing ("boosting") the radiation dose for patients with non-small cell lung carcinoma to the individual maximal dose which can safely be given. The question is if patients should receive this boost on the whole tumor on part of the tumor. Therefore patients are randomized for one of these two treatment options. All patients will receive 24 radiations. Dose increasement will be enabled by a so called integrated boost.
Furthermore:
- PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and four hours post injection.
Read the detailed description
A randomized phase II study will be conducted in patients with inoperable stage IB, II or III non-small cell lung cancer (NSCLC). The patients will be randomized to receive the standard 66 Gy given in 24 fractions of 2.75 Gy with an integrated boost to the primary tumor as a whole (Arm A) or with an integrated boost to the 50% SUVmax area of the primary tumor (of the pre-treatment FDG-PET scan) (Arm B). Both treatment arms may be combined with chemotherapy (concurrent or sequential). Patients fulfilling the eligibility criteria will be registered in the study, and an initial radiotherapy treatment planning will be performed. When an integrated boost to the primary tumor as a whole up to 72 Gy is not possible because of dose constraints, the patient will receive 66 Gy or lower according to the normal tissue tolerance (see below). They will not be randomized, but will be followed in the trial. As such, it will be clear which proportion of patients can receive an integrated boost and what the outcome is when dose-escalation is not possible.
Stage IB-II patients receive radiotherapy alone, and stage III patients combined chemotherapy and radiation. The patients may have received induction chemotherapy up to two cycles before registration in this trial. The statistical calculations have been performed to deal with this patient heterogeneity.
The primary objective of this study is to determine the local progression-free survival (LPFS)at 1 year.
Secondary objectives will be
- Toxicity as a function of radiotherapy dose and volume of the tissue irradiated.
- Overall survival.
- Quality of life
Furthermore:
- PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and four hours post injection.
- Dynamic Contrast-Enhanced CT imaging
- Conditions
- NSCLC
- Being tested
- Radiotherapy
- Keywords
- Non small cell lung cancer, Inoperable, HX4
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Whole tumor boost | Other | Patients in this arm will receive radiotherapy (66Gy) in 24 fractions of 2.75 Gy with an integrated boost to the primary tumor as a whole Receives: Radiation: Radiotherapy |
| Boost 50% SUV area | Other | Patients in this arm receive radiotherapy (66Gy) in 24 fractions of 2.75Gy with an integrated boost to the 50% SUVmax area of the primary tumor (of the pre-treatment FDG-PET-CT scan) Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local progression-free survival at 1 year
Measured: 1 year
Secondary outcomes (3)
Toxicity
Measured: 1 year
Overall survival
Measured: 1 year
Quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionDec 2020
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- José Belderbos, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024829
- Sponsor's protocol ID
- PET Boost
- Acronym
- PET Boost
- Status last verified
- Jan 2022
- First submitted
- 1 Dec 2009
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cooke SA, Belderbos JSA, Stam B, Reymen B, Lambrecht M, Fredberg Persson G, Faivre-Finn C, Dieleman EMT, van Diessen J, de Ruysscher D, Sonke JJ. Esophageal Toxicity After Dose-Escalated Radiation Therapy for Stage II-III Non-Small Cell Lung Cancer: A Secondary Analysis of the Phase 2 Randomized ARTFORCE PET-Boost Trial. Int J Radiat Oncol Biol Phys. 2025 Aug 1;122(5):1227-1237. doi: 10.1016/j.ijrobp.2025.03.001. Epub 2025 Mar 28.
PubMed 40156600Cooke SA, de Ruysscher D, Reymen B, Lambrecht M, Fredberg Persson G, Faivre-Finn C, Dieleman EMT, Lewensohn R, van Diessen JNA, Sikorska K, Lalezari F, Vogel W, van Elmpt W, Damen EMF, Sonke JJ, Belderbos JSA. 18F-FDG-PET guided vs whole tumour radiotherapy dose escalation in patients with locally advanced non-small cell lung cancer (PET-Boost): Results from a randomised clinical trial. Radiother Oncol. 2023 Apr;181:109492. doi: 10.1016/j.radonc.2023.109492. Epub 2023 Jan 24.
PubMed 36706958van Diessen J, De Ruysscher D, Sonke JJ, Damen E, Sikorska K, Reymen B, van Elmpt W, Westman G, Fredberg Persson G, Dieleman E, Bjorkestrand H, Faivre-Finn C, Belderbos J. The acute and late toxicity results of a randomized phase II dose-escalation trial in non-small cell lung cancer (PET-boost trial). Radiother Oncol. 2019 Feb;131:166-173. doi: 10.1016/j.radonc.2018.09.019. Epub 2018 Oct 13.
PubMed 30327236Defraene G, La Fontaine M, van Kranen S, Reymen B, Belderbos J, Sonke JJ, De Ruysscher D. Radiation-Induced Lung Density Changes on CT Scan for NSCLC: No Impact of Dose-Escalation Level or Volume. Int J Radiat Oncol Biol Phys. 2018 Nov 1;102(3):642-650. doi: 10.1016/j.ijrobp.2018.06.038. Epub 2018 Jul 2.
PubMed 30244882van Elmpt W, Zegers CML, Reymen B, Even AJG, Dingemans AC, Oellers M, Wildberger JE, Mottaghy FM, Das M, Troost EGC, Lambin P. Multiparametric imaging of patient and tumour heterogeneity in non-small-cell lung cancer: quantification of tumour hypoxia, metabolism and perfusion. Eur J Nucl Med Mol Imaging. 2016 Feb;43(2):240-248. doi: 10.1007/s00259-015-3169-4. Epub 2015 Sep 4.
PubMed 26338178
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation by Boosting Radiation Dose Within the Primary Tumor on the Basis of a Pre-treatment FDG-PET-CT Scan in Stage IB, II and III NSCLC: a Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT01024829
- Acronym / sponsor ID
- PET Boost / PET Boost
- Conditions
- NSCLC
- Keywords
- Non small cell lung cancer, Inoperable, HX4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- European Union
- Study start
- May 2010
- Primary completion
- Dec 2020 (actual)
- Study completion
- Mar 2022 (estimated)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increasing ("boosting") the radiation dose for patients with non-small cell lung carcinoma to the individual maximal dose which can safely be given. The question is if patients should receive this boost on the whole tumor on part of the tumor. Therefore patients are randomized for one of these two treatment options. All patients will receive 24 radiations. Dose increasement will be enabled by a so called integrated boost.
Furthermore:
- PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and four hours post injection.
Detailed description
A randomized phase II study will be conducted in patients with inoperable stage IB, II or III non-small cell lung cancer (NSCLC). The patients will be randomized to receive the standard 66 Gy given in 24 fractions of 2.75 Gy with an integrated boost to the primary tumor as a whole (Arm A) or with an integrated boost to the 50% SUVmax area of the primary tumor (of the pre-treatment FDG-PET scan) (Arm B). Both treatment arms may be combined with chemotherapy (concurrent or sequential). Patients fulfilling the eligibility criteria will be registered in the study, and an initial radiotherapy treatment planning will be performed. When an integrated boost to the primary tumor as a whole up to 72 Gy is not possible because of dose constraints, the patient will receive 66 Gy or lower according to the normal tissue tolerance (see below). They will not be randomized, but will be followed in the trial. As such, it will be clear which proportion of patients can receive an integrated boost and what the outcome is when dose-escalation is not possible.
Stage IB-II patients receive radiotherapy alone, and stage III patients combined chemotherapy and radiation. The patients may have received induction chemotherapy up to two cycles before registration in this trial. The statistical calculations have been performed to deal with this patient heterogeneity.
The primary objective of this study is to determine the local progression-free survival (LPFS)at 1 year.
Secondary objectives will be
- Toxicity as a function of radiotherapy dose and volume of the tissue irradiated.
- Overall survival.
- Quality of life
Furthermore:
- PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and four hours post injection.
- Dynamic Contrast-Enhanced CT imaging
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole tumor boost | Other | Radiation: RadiotherapyPatients in this arm will receive radiotherapy (66Gy) in 24 fractions of 2.75 Gy with an integrated boost to the primary tumor as a whole |
| Boost 50% SUV area | Other | Radiation: RadiotherapyPatients in this arm receive radiotherapy (66Gy) in 24 fractions of 2.75Gy with an integrated boost to the 50% SUVmax area of the primary tumor (of the pre-treatment FDG-PET-CT scan) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients > 18 years with any subtype of pathologically proven (biopsy or cytology), non-small cell lung cancer. The diagnosis may be established from biopsy or cytology obtained from the primary tumor and/ or from metastatic lymph nodes.
- Minimal diameter of the primary tumor 4 cm, this to allow for boosting of sub-volumes.
- UICC TNM Stage T2-4, N0-3, M0 disease (TNM definition see appendix 2).
- Only stage IB-II patients who are nog candidates for surgery are study candidates.
- Measurable disease at registration.
Key exclusion criteria (7 listed)
- Prior radiotherapy to the thorax.
- Clinical superior vena cava syndrome, malignant pleural effusion or malignant pericardial effusion.
- T4, specified as:Tumor growth in large blood vessels on spiral CT scan or encasement >50%
- multiple nodules in the same or ipsilateral lobe(s).
- Post-obstructive atelectasis or infiltration that cannot be distinguished from tumor on a CT-PET scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy | Radiation | Boost 50% SUV area, Whole tumor boost |
Primary outcome
Local progression-free survival at 1 year
Time frame: 1 year
3 secondary outcomes
Toxicity
Time frame: 1 year
Overall survival
Time frame: 1 year
Quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Derived from this study: PubMed 40156600Cooke SA, Belderbos JSA, Stam B, Reymen B, Lambrecht M, Fredberg Persson G, Faivre-Finn C, Dieleman EMT, van Diessen J, de Ruysscher D, Sonke JJ. Esophageal Toxicity After Dose-Escalated Radiation Therapy for Stage II-III Non-Small Cell Lung Cancer: A Secondary Analysis of the Phase 2 Randomized ARTFORCE PET-Boost Trial. Int J Radiat Oncol Biol Phys. 2025 Aug 1;122(5):1227-1237. doi: 10.1016/j.ijrobp.2025.03.001. Epub 2025 Mar 28.
- Derived from this study: PubMed 36706958Cooke SA, de Ruysscher D, Reymen B, Lambrecht M, Fredberg Persson G, Faivre-Finn C, Dieleman EMT, Lewensohn R, van Diessen JNA, Sikorska K, Lalezari F, Vogel W, van Elmpt W, Damen EMF, Sonke JJ, Belderbos JSA. 18F-FDG-PET guided vs whole tumour radiotherapy dose escalation in patients with locally advanced non-small cell lung cancer (PET-Boost): Results from a randomised clinical trial. Radiother Oncol. 2023 Apr;181:109492. doi: 10.1016/j.radonc.2023.109492. Epub 2023 Jan 24.
- Derived from this study: PubMed 30327236van Diessen J, De Ruysscher D, Sonke JJ, Damen E, Sikorska K, Reymen B, van Elmpt W, Westman G, Fredberg Persson G, Dieleman E, Bjorkestrand H, Faivre-Finn C, Belderbos J. The acute and late toxicity results of a randomized phase II dose-escalation trial in non-small cell lung cancer (PET-boost trial). Radiother Oncol. 2019 Feb;131:166-173. doi: 10.1016/j.radonc.2018.09.019. Epub 2018 Oct 13.
- Derived from this study: PubMed 30244882Defraene G, La Fontaine M, van Kranen S, Reymen B, Belderbos J, Sonke JJ, De Ruysscher D. Radiation-Induced Lung Density Changes on CT Scan for NSCLC: No Impact of Dose-Escalation Level or Volume. Int J Radiat Oncol Biol Phys. 2018 Nov 1;102(3):642-650. doi: 10.1016/j.ijrobp.2018.06.038. Epub 2018 Jul 2.
- Derived from this study: PubMed 26338178van Elmpt W, Zegers CML, Reymen B, Even AJG, Dingemans AC, Oellers M, Wildberger JE, Mottaghy FM, Das M, Troost EGC, Lambin P. Multiparametric imaging of patient and tumour heterogeneity in non-small-cell lung cancer: quantification of tumour hypoxia, metabolism and perfusion. Eur J Nucl Med Mol Imaging. 2016 Feb;43(2):240-248. doi: 10.1007/s00259-015-3169-4. Epub 2015 Sep 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Belderbos, MD, PhD principal investigator
The Netherlands Cancer Institute
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with NSCLC, run by The Netherlands Cancer Institute at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, Belgium, Denmark, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local progression-free survival at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01024829, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.