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| Name | Class |
|---|---|
| Dutch Society of Physicians for Pulmonology and Tuberculosis | OTHER |
| Erasmus Medical Center | OTHER |
| VieCuri Medical Centre | OTHER |
| AstraZeneca |
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There is no detailed information available on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of elderly patients. Reliable tools are needed to distinguish the subgroup of fit patients from frail patients.
Lung cancer is a problem of the elderly: 30% of the lung cancer patients are aged ≥ 75 years. Due to underrepresentation of elderly patients in clinical trials there is a lack of evidence to select the optimal treatment strategy for these patients. Concurrent radiochemotherapy (RCHT) has been recognised as the standard treatment of stage III NSCLC patients with a good performance status. Evidence for this treatment was gained in clinical trials that mostly excluded elderly patients. Furthermore, the survival gain obtained with combined RCHT, comes with a significant increase in toxicity. Therefore, information on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of medically fit elderly patients is still lacking. Moreover, reliable tools are needed to distinguish the subgroup of fit patients from frail patients, i.e. those expected to experience important toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with any subtype of NSCLC, primary UICC Stage III, age ≥ 75 years | All registered patients will undergo a geriatric assessment to assess vulnerability. Based on this assessment, patients are offered treatment according to the discretion of the physician and patient. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation GA with QAS (quality adjusted survival) | To corellate results of the geriatric assessment with quality-adjusted survival (QAS) after radical intent therapy in patients with stage III NSCLC ≥75 years | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Geriatric assessment | To perform a geriatric assessment in stage III NSCLC patients to distinguish patients fit enough to undergo intensified treatment and to develop a reliable and clinically applicable geriatric screening instrument to guide treatment decisions in stage III NSCLC | Baseline |
| Medical comparison between treatments |
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Inclusion criteria (according to the protocol):
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Patients aged ≥ 75 years, with any subtype of NSCLC, stage III
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| Name | Affiliation | Role |
|---|---|---|
| Judith van Loon, MD, PhD | Maastro (radiotherapist) | Principal Investigator |
| Anne-Marie Dingemans, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Mariska Janssen-Heijnen, PhD | VieCuri Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuisgroep Twente | Almelo | 7609 PP | Netherlands | |||
| Gelre ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29651598 | Derived | Driessen EJM, van Loon JGM, Maas HA, Dingemans AC, Janssen-Heijnen MLG. Geriatric Assessment for Older Patients with Non-small Cell Lung Cancer: Daily Practice of Centers Participating in the NVALT25-ELDAPT Trial. Lung. 2018 Aug;196(4):463-468. doi: 10.1007/s00408-018-0116-8. Epub 2018 Apr 12. |
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| INDUSTRY |
| Dutch Cancer Society | OTHER |
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To compare different treatment strategies for fit elderly patients with respect to overall and quality adjusted survival |
| 5 years |
| Cost-effectiveness | To compare cost-effectiveness of sequential and concurrent RCHT for fit elderly patients with stage III NSCLC | End of study |
| Development and validation of geriatric screening instrument | To develop and validate a clinically applicable geriatric screening instrument that enables appropriate treatment stratification in the elderly NSCLC patient | 5 years |
| Flow chart | To develop a flow chart for cost-effective clinical decision-making, in clinical practice | 5 years |
| Predictive value | To determine the predictive value of saliva biomarkers on QAS in elderly patients with stage III NSCLC | 5 years |
| Apeldoorn |
| 7334 DZ |
| Netherlands |
| Radiotherapiegroep Arnhem | Arnhem | 6815 AD | Netherlands |
| Rijnstate | Arnhem | 6815 AD | Netherlands |
| Deventer Hospital | Deventer | 7416 SE | Netherlands |
| Gelderse Vallei | Ede | 6716 RP | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| Máxima MC | Eindhoven | 5631 BM | Netherlands |
| Medisch Spectrum Twente | Enschede | 7500 KA | Netherlands |
| Rivas Zorggroep | Gorinchem | 4200 AB | Netherlands |
| Groen Hart Ziekenhuis | Gouda | 2803 HH | Netherlands |
| Zuyderland | Heerlen | 6419 PC | Netherlands |
| Maastro | Maastricht | 6229 ET | Netherlands |
| MUMC+ | Maastricht | 6229 HX | Netherlands |
| Canisius-Wilhelmina Hospital | Nijmegen | 6532 SZ | Netherlands |
| Laurentius Hospital | Roermond | 6043 VC | Netherlands |
| Maasstad Ziekenhuis | Rotterdam | 3079 DZ | Netherlands |
| Ikazia Ziekenhuis | Rotterdam | 3083 AN | Netherlands |
| Haga Ziekenhuis | The Hague | 2504 LN | Netherlands |
| Haaglanden MC | The Hague | 2512 VA | Netherlands |
| VieCuri MC | Venlo | 5912 BL | Netherlands |
| Zaans MC | Zaandam | 1502 DV | Netherlands |