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| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
| The Netherlands Cancer Institute | OTHER |
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For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.
For this group of patients, brain metastases are one of the major sites of tumor failure. Radical therapy of symptomatic brain metastases is seldom possible and only very rarely, long term survival can be achieved. PCI has shown to reduce the incidence of brain metastases in patients with non-small cell lung cancer to the same extent as in limited disease small-cell lung cancer. However, the exact value of PCI in stage III NSCLC patient, treated with contemporary chemo-radiation schedule with or without surgery, remains unsettled. Therefore this study is launched, in order to investigate whether PCI should become the standard of care in patients with stage III NSCLC who are treated with curative intention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic Cranial Irradiation | Experimental |
| |
| Observation | No Intervention | Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic Cranial Irradiation | Radiation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients developing symptomatic brain metastasis | 24 months after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to develop neurological symptoms (confirmed or unconfirmed by imaging) | 24 months after randomisation | |
| Measurement of side effects (CTCAE3.0) | 24 months after randomisation | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk De Ruysscher, MD, PhD | NVALT oncology foundation | Principal Investigator |
| Harry Groen, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU Medical Center | Amsterdam | Amsterdam | Netherlands | |||
| Maastro Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31733490 | Derived | Witlox WJA, Ramaekers BLT, Joore MA, Dingemans AC, Praag J, Belderbos J, Tissing-Tan C, Herder G, Haitjema T, Ubbels JF, Lagerwaard J, El Sharouni SY, Stigt JA, Smit EF, van Tinteren H, van der Noort V, Groen HJM, De Ruysscher DKM. Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study. Radiother Oncol. 2020 Mar;144:65-71. doi: 10.1016/j.radonc.2019.10.016. Epub 2019 Nov 14. |
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| Quality of Life |
Measured by QLQ-C30 and EuroQol 5D |
| 24 months after randomisation |
| Maastricht |
| Limburg |
| 6229 ET |
| Netherlands |
| UMCG Groningen | Groningen | Provincie Groningen | Netherlands |
| UMC Utrecht | Utrecht | Utrecht | Netherlands |
| The Netherlands Cancer Institute | Amsterdam | Netherlands |
| RT Insitute Stedendriehoek | Deventer | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Dr. Bernard Verbeeten Institute | Tilburg | Netherlands |
| Isala Klinieken | Zwolle | Netherlands |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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