Non Small Cell Lung Cancer Stage IIINCT03055715
Prognostic Evaluation of Tumor Volume and Its Changes in Radical Radiotherapy of Advanced NSCLC
An observational study of Non Small Cell Lung Cancer Stage III, run by Martin-Luther-Universität Halle-Wittenberg at 22 sites in 5 countries.
Trial summary
The aim of the study is to retrospectively monitor the 'gross tumor volume' (GTV) before initiation of radiotherapy and its changes during radiotherapy and to correlate them with retrospectively recorded patient data, as well as with prognostic and therapeutic outcome after definite radiotherapy of locally advanced… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non Small Cell Lung Cancer Stage III
- How many people
- 346 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 1 Apr 2017to 1 Apr 2018
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced, inoperable stage III (A and B) non-small-cell lung cancer without prior surgery
Who may be able to join
- Histologically confirmed NSCLC (Adeno / SCC) Stage UICC III A or B
- CT based radiation treatment planning (PET- or PET-CT-based if available)
- completed curative-intended radiotherapy ± chemotherapy (achieved total dose ≥ 60 Gy normofractionated or ≥ 50 Gy hypofractionated)
Who cannot join
- Stereotactic radiotherapy
- Second malignancy <5 years before diagnosis of NSCLC
- Pleural effusion ipsilateral, extensive atelectasis ipsilateral
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Germany18 sites
Department of Radiooncology, Charité Campus Mitte und Campus Virchow Berlin
Berlin, 10117
Department of Radiooncology Cologne
Cologne, 50937
Department of Radiooncology Dresden
Dresden, 01307
Department of Radiooncology, Duesseldorf
Düsseldorf, 40210
Department of Radiooncology, Düsseldorf
Düsseldorf, 40225
Department of Radiooncology, Erlangen
Erlangen
Department of Radiooncology, Halle
Halle, 06120
Department of Radiooncology, Hamburg
Hamburg, 20246
Department of Radiooncology, Hannover
Hanover, 30625
Department of Radiooncology, Heidelberg
Heidelberg, 69120
Department of Radiooncology, Jena
Jena, 07743
Department of Radiooncology, Kiel
Kiel, 24105
Department of Radiooncology Lübeck
Lübeck, 23562
Department of Radiooncology, Mannheim
Mannheim, 68167
Department of Radiooncology, Munich (LMU, Campus Großhadern)
Munich, 81377
Department of Radiooncology, Munich (TUM)
Munich
Department of Radiooncology, Muenster
Münster, 48143
Department of Radiooncology, Regensburg
Regensburg, 93047
Austria1 site
Univ.-Klinik für Strahlentherapie-Radioonkologie
Innsbruck, 6020
About this study
Official title: Multicentric Retrospective Prognostic Evaluation of Tumor Volume and Their Change in the Curative-intended, Radical Radiotherapy of Locally Advanced NSCLC
The aim of the study is to retrospectively monitor the 'gross tumor volume' (GTV) before initiation of radiotherapy and its changes during radiotherapy and to correlate them with retrospectively recorded patient data, as well as with prognostic and therapeutic outcome after definite radiotherapy of locally advanced NSCLC in stage UICC III.
Read the detailed description
The prognostic relevance of the 'gross tumor volume' (GTV) in radiotherapy of advanced non-small-cell lung cancer (NSCLC) in stage III is adressed in a limited number of studies in the literature. The review article by Dubben et al., that comprises data until 1998, highlights the GTV as an important indicator and influencing factor for the therapeutic success after radiotherapy, albeit not being dominant over the T-stage (Dubben et al. 1988). In general, an increase in tumor volume correlates with a higher T-stage (Martel et al. 1997), but no congruence can neccessarily be assumed between the tumor volume and the T-determinator. Since the TNM-classification is primarily surgical however, it also does not provide sufficient information for prognosis when surgical therapy is not the first choice.
Available evidence suggests that the GTV in particular at the beginning of therapy acts as a statistically significant prognostic indicator regarding overall survival and / or local tumor control (Martel et al. 1997; Bradley et al. 2002; Basaki et al. 2006; Etiz et al. 2002; Werner-Wasik et al. 2001; Wer-ner-Wasik et al. 2008; Stinchcombe et al. 2006; Dehing-Oberije et al. 2008; Willner et al. 2002; Ball et al. 2013). A direct comparison between different studies is, however, often hampered due to the large variation of measurement time points during therapy, as well as the employed definition of the tumor volume. For example, all studies include patients whose GTV was determined after (neoadjuvant) chemotherapy. In addition, three studies even combine the tumor volume of the primary tumor with affected lymph nodes (Etiz et al. 2002; Werner-Wasik et al. 2008; Dehing-Oberije et al. 2008). Furthermore, no agreements can be found in the literature concerning volume changes during therapy. Nonetheless, all studies report a volume reduction at the end of therapy, albeit not always significant. In a study containing 10 patients treated with helical Tomotherapy, the authors observed a relative median tumor reduction during therapy of 1.2% per day (0.6-2.3%) (Kupelian et al. 2005).
The response of NSCLC to radiotherapy with or without chemotherapy is slow (Woodford et al. 2007) with tumors reaching their maximum response or minimal volume after 5-11 months after exposure (Werner-Wasik et al. 2001). If the tumor volume is determined too early, i.e. directly after the end of therapy, the results can lead to misinterpretation resulting in an overestimation of the tumor volume or correspondingly an underestimation of the therapeutic response (Siker et al. 2006). According to Bell et al., the predictive value of tumor volume changes in the first 18 months after radiotherapy is of particular importance. During this time, a significantly increased mortality was observed for larger tumor volumes.
Incorporation of a PET/CT in the context of the radiaton plan is advantageous with respect to the precise traget-volume definition and sparing of risk organs (Ruysscher et al. 2005; Nestle et al. 2006; Lavrenkov et al. 2005; van Baardwijk et al. 2007; Edet-Sanson et al. 2012; Ruysscher und Kirsch 2010; As-hamalla et al. 2005; Bradley et al. 2004; van Baardwijk et al. 2006; Vanuytsel et al. 2000). The superiority of PET compared to stand-alone CT was also shown in two meta-analysis (Gould et al. 2001; Gould et al. 2003). The importance of the 'standardized uptake value' (SUV) or the metabolic tumor volume (MTV) as well as the change in these parameters during radiotherapy has been repeatedly demonstrated (Berghmans et al. 2008, Gillham et al. 2008; Zhang et al. 2011; van Elmpt et al. 2012; Edet-Sanson et al. 2012; van Baardwijk et al. 2007; Vera et al. 2014; Vanuytsel et al. 2000; Feifei Na et al. 2014; Lopez Guerra et al. 2012; Lee et al. 2007; Lee et al. 2012; Huang et al. 2011; Xiang et al. 2012). These studies show partly a statistically significant correlation between tumorale FDG-accumulation before, during or after radiotherapy, or the decreasing accumulation during radiotherapy, respectively, and the overall survival. The results, however, suffer from a large uncertainty regarding the distinct influence corresponding to the SUV. Other studies report a significantly weaker association of the SUV and survival (Hoang et al. 2008; IKUSHIMA et al. 2010; Lopez Guerra et al. 2012). Due to the dynamic variations in the SUV and MTV during radiotherapy, a change in the prognostic validity during radiotherapy can be assumed. According to van Elmpt and others, the FDG uptake during the second (van Elmpt et al. 2012; Zhang et al. 2011) or fifth week of exposure is crucial for survival (Edet-Sanson et al. 2012). Work by van Baardwijk et al. shows an increase in the SUV in some patients during the first week of therapy, which is explained by radiation-triggered inflammation and tumor-biological changes due to radiotherapy (van Baardwijk et al. 2007). The results demonstrate that the appearance of tumor necrosis during radiotherapy or changes in the metabolic tumor situation or oxygenation affect the SUV parameter crucially (Hoang et al. 2008, Huang et al. 2014; Huang et al. 2011). In this context, tumorhypoxia and the corresponding effects on the metabolism of glucose are of particularly importance: A hypoxia-simulated upregulation of the membranic glucose transporter with consecutive increase of cellular FDG uptage can lead to a false SUV value, calling for a combination of SUV or MTV with other prognostic parameters as well as hypoxia-specific imaging (FMISO-PET) (Ikushima et al. 2010, Berghmans et al. 2008). Consequently, the optimal timevpoint for carrying out a PET during / after radiotherapy is not well defined, especially when the protracted tumor response after completion of radiotherapy is taken into account, leaving the integration of additional PET measurements during radiotherapy exclusively to clinical studies.
In conclusion, evidence from available literature regarding the prognostic and predictive value of tumor volume before and particularly its changes during radiotherapy of locally advanced NSCLC is conflicting and inconclusive. Currently available studies often include only a small number of patients with partly overlapping patient cohorts. Current data is additionally limited due to the highly heterogeneous GTV detection time points as well as the definition and detection methodology of tumor volumes.
Based on the observation that a significant tumor volume reduction occurs during radiotherapy, a reevaluation of the tumor volume during radiotherapy could allow an adaptation of the target volumes with dose escalating in the tumor area, while at the same time, improving the protection of organs at risk.
The prognostic or predictive significance of absolute tumor volumes or their change under radiotherapy is to be evaluated multicentrically and its integration into already existing prognostic models is to be multicentrically validated.
- Conditions
- Non Small Cell Lung Cancer Stage III
- Keywords
- NSCLC, Radiotherapy, young DEGRO, tumor volume, lung cancer, radiochemotherapy, prognostic factors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced NSCLC-patients | Inoperable stage III (A and B) non-small-cell lung cancer (NSCLC) with indication for radical radiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (months)
from the start of Radiotherapy until death / last seen during follow up
Measured: 5 months
Secondary outcomes (3)
Absolute Basal Gross Tumor Volume (ml) before Radiotherapy (GTV1)
in ml (cc) as detected by initial planning CT or diagnostic CT before the start of RT
Measured: 5 months
Absolute Gross Tumor Volume before Radiation Boost (GTV2)
in ml (cc) as detected in re-planning CT or CBCT before initiation of radiation boost
Measured: 5 months
Relative Gross Tumor Volume Changes (delta GTV related to basal GTV)
percental increase / decrease of GTV in relation to basal GTV1
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Apr 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer Stage IIIStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Radiation Oncology Working Group of the German Cancer Society
- Responsible party
- Principal investigator, Christian Ostheimer, MD, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Christian Ostheimer, MD, Principal investigator, Klinik fuer Strahlentherapie, Martin-Luther-Universitaet Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055715
- Sponsor's protocol ID
- ARO 2017-1
- Status last verified
- May 2018
- First submitted
- 14 Feb 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Retrospective Prognostic Evaluation of Tumor Volume and Their Change in the Curative-intended, Radical Radiotherapy of Locally Advanced NSCLC
- ClinicalTrials.gov ID
- NCT03055715
- Acronym / sponsor ID
- ARO 2017-1
- Conditions
- Non Small Cell Lung Cancer Stage III
- Keywords
- NSCLC, Radiotherapy, young DEGRO, tumor volume, lung cancer, radiochemotherapy, prognostic factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- Radiation Oncology Working Group of the German Cancer Society
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 16 Feb 2017 (actual)
- 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.
The aim of the study is to retrospectively monitor the 'gross tumor volume' (GTV) before initiation of radiotherapy and its changes during radiotherapy and to correlate them with retrospectively recorded patient data, as well as with prognostic and therapeutic outcome after definite radiotherapy of locally advanced NSCLC in stage UICC III.
Detailed description
The prognostic relevance of the 'gross tumor volume' (GTV) in radiotherapy of advanced non-small-cell lung cancer (NSCLC) in stage III is adressed in a limited number of studies in the literature. The review article by Dubben et al., that comprises data until 1998, highlights the GTV as an important indicator and influencing factor for the therapeutic success after radiotherapy, albeit not being dominant over the T-stage (Dubben et al. 1988). In general, an increase in tumor volume correlates with a higher T-stage (Martel et al. 1997), but no congruence can neccessarily be assumed between the tumor volume and the T-determinator. Since the TNM-classification is primarily surgical however, it also does not provide sufficient information for prognosis when surgical therapy is not the first choice.
Available evidence suggests that the GTV in particular at the beginning of therapy acts as a statistically significant prognostic indicator regarding overall survival and / or local tumor control (Martel et al. 1997; Bradley et al. 2002; Basaki et al. 2006; Etiz et al. 2002; Werner-Wasik et al. 2001; Wer-ner-Wasik et al. 2008; Stinchcombe et al. 2006; Dehing-Oberije et al. 2008; Willner et al. 2002; Ball et al. 2013). A direct comparison between different studies is, however, often hampered due to the large variation of measurement time points during therapy, as well as the employed definition of the tumor volume. For example, all studies include patients whose GTV was determined after (neoadjuvant) chemotherapy. In addition, three studies even combine the tumor volume of the primary tumor with affected lymph nodes (Etiz et al. 2002; Werner-Wasik et al. 2008; Dehing-Oberije et al. 2008). Furthermore, no agreements can be found in the literature concerning volume changes during therapy. Nonetheless, all studies report a volume reduction at the end of therapy, albeit not always significant. In a study containing 10 patients treated with helical Tomotherapy, the authors observed a relative median tumor reduction during therapy of 1.2% per day (0.6-2.3%) (Kupelian et al. 2005).
The response of NSCLC to radiotherapy with or without chemotherapy is slow (Woodford et al. 2007) with tumors reaching their maximum response or minimal volume after 5-11 months after exposure (Werner-Wasik et al. 2001). If the tumor volume is determined too early, i.e. directly after the end of therapy, the results can lead to misinterpretation resulting in an overestimation of the tumor volume or correspondingly an underestimation of the therapeutic response (Siker et al. 2006). According to Bell et al., the predictive value of tumor volume changes in the first 18 months after radiotherapy is of particular importance. During this time, a significantly increased mortality was observed for larger tumor volumes.
Incorporation of a PET/CT in the context of the radiaton plan is advantageous with respect to the precise traget-volume definition and sparing of risk organs (Ruysscher et al. 2005; Nestle et al. 2006; Lavrenkov et al. 2005; van Baardwijk et al. 2007; Edet-Sanson et al. 2012; Ruysscher und Kirsch 2010; As-hamalla et al. 2005; Bradley et al. 2004; van Baardwijk et al. 2006; Vanuytsel et al. 2000). The superiority of PET compared to stand-alone CT was also shown in two meta-analysis (Gould et al. 2001; Gould et al. 2003). The importance of the 'standardized uptake value' (SUV) or the metabolic tumor volume (MTV) as well as the change in these parameters during radiotherapy has been repeatedly demonstrated (Berghmans et al. 2008, Gillham et al. 2008; Zhang et al. 2011; van Elmpt et al. 2012; Edet-Sanson et al. 2012; van Baardwijk et al. 2007; Vera et al. 2014; Vanuytsel et al. 2000; Feifei Na et al. 2014; Lopez Guerra et al. 2012; Lee et al. 2007; Lee et al. 2012; Huang et al. 2011; Xiang et al. 2012). These studies show partly a statistically significant correlation between tumorale FDG-accumulation before, during or after radiotherapy, or the decreasing accumulation during radiotherapy, respectively, and the overall survival. The results, however, suffer from a large uncertainty regarding the distinct influence corresponding to the SUV. Other studies report a significantly weaker association of the SUV and survival (Hoang et al. 2008; IKUSHIMA et al. 2010; Lopez Guerra et al. 2012). Due to the dynamic variations in the SUV and MTV during radiotherapy, a change in the prognostic validity during radiotherapy can be assumed. According to van Elmpt and others, the FDG uptake during the second (van Elmpt et al. 2012; Zhang et al. 2011) or fifth week of exposure is crucial for survival (Edet-Sanson et al. 2012). Work by van Baardwijk et al. shows an increase in the SUV in some patients during the first week of therapy, which is explained by radiation-triggered inflammation and tumor-biological changes due to radiotherapy (van Baardwijk et al. 2007). The results demonstrate that the appearance of tumor necrosis during radiotherapy or changes in the metabolic tumor situation or oxygenation affect the SUV parameter crucially (Hoang et al. 2008, Huang et al. 2014; Huang et al. 2011). In this context, tumorhypoxia and the corresponding effects on the metabolism of glucose are of particularly importance: A hypoxia-simulated upregulation of the membranic glucose transporter with consecutive increase of cellular FDG uptage can lead to a false SUV value, calling for a combination of SUV or MTV with other prognostic parameters as well as hypoxia-specific imaging (FMISO-PET) (Ikushima et al. 2010, Berghmans et al. 2008). Consequently, the optimal timevpoint for carrying out a PET during / after radiotherapy is not well defined, especially when the protracted tumor response after completion of radiotherapy is taken into account, leaving the integration of additional PET measurements during radiotherapy exclusively to clinical studies.
In conclusion, evidence from available literature regarding the prognostic and predictive value of tumor volume before and particularly its changes during radiotherapy of locally advanced NSCLC is conflicting and inconclusive. Currently available studies often include only a small number of patients with partly overlapping patient cohorts. Current data is additionally limited due to the highly heterogeneous GTV detection time points as well as the definition and detection methodology of tumor volumes.
Based on the observation that a significant tumor volume reduction occurs during radiotherapy, a reevaluation of the tumor volume during radiotherapy could allow an adaptation of the target volumes with dose escalating in the tumor area, while at the same time, improving the protection of organs at risk.
The prognostic or predictive significance of absolute tumor volumes or their change under radiotherapy is to be evaluated multicentrically and its integration into already existing prognostic models is to be multicentrically validated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally advanced NSCLC-patients | – | –Inoperable stage III (A and B) non-small-cell lung cancer (NSCLC) with indication for radical radiotherapy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced, inoperable stage III (A and B) non-small-cell lung cancer without prior surgery
Key inclusion criteria (3 listed)
- Histologically confirmed NSCLC (Adeno / SCC) Stage UICC III A or B
- CT based radiation treatment planning (PET- or PET-CT-based if available)
- completed curative-intended radiotherapy ± chemotherapy (achieved total dose ≥ 60 Gy normofractionated or ≥ 50 Gy hypofractionated)
Key exclusion criteria (3 listed)
- Stereotactic radiotherapy
- Second malignancy <5 years before diagnosis of NSCLC
- Pleural effusion ipsilateral, extensive atelectasis ipsilateral
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (months)
Time frame: 5 months
from the start of Radiotherapy until death / last seen during follow up
3 secondary outcomes
Absolute Basal Gross Tumor Volume (ml) before Radiotherapy (GTV1)
Time frame: 5 months
Absolute Gross Tumor Volume before Radiation Boost (GTV2)
Time frame: 5 months
Relative Gross Tumor Volume Changes (delta GTV related to basal GTV)
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Christian Ostheimer, MD principal investigator
Klinik fuer Strahlentherapie, Martin-Luther-Universitaet Halle-Wittenberg
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer Stage III, run by Martin-Luther-Universität Halle-Wittenberg at 22 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, Austria, Belgium, Spain, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Survival (months) (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.