Clinical trial NCT01282437: Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC
Official title: Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer (NSCLC)
Radical Treatment
Stage III Non-Small Cell Lung Cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
name: The Netherlands Cancer Institute
First posted: 2011-01-25
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* UICC stage IIIA or IIIB (without malignant pleural of pericardial effusion) non-small cell lung cancer (histology or cytology)
* Whole body FDG-PET-scan before start of therapy available: No distant metastases
* CT or MRI of the brain before the start of radical therapy available: No brain metastases
* Platinum-based chemotherapy is mandatory
* Radical local therapy: concurrent of sequential chemotherapy (platinum-based) and radiotherapy with or without surgery
* Radiotherapy dose without surgery at least a biological equivalent of 60Gy
* No prior cranial irradiation
* Patients must sign a study-specific informed consent at the time of registration

Exclusion Criteria:

* The opposite of the above

Primary outcomes:
measure: Proportion of patients developing symptomatic brain metastasis
timeFrame: 24 months after randomisation
Secondary outcomes:
measure: Time to develop neurological symptoms (confirmed or unconfirmed by imaging)
timeFrame: 24 months after randomisation
measure: Measurement of side effects (CTCAE3.0)
timeFrame: 24 months after randomisation
measure: Quality of Life
timeFrame: 24 months after randomisation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastro Clinic
state: Limburg
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Deventer
country: Netherlands
facility: RT Insitute Stedendriehoek
city: Groningen
country: Netherlands
facility: UMCG Groningen
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Tilburg
country: Netherlands
facility: Dr. Bernard Verbeeten Institute
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: NVALT oncology foundation
name: Dirk De Ruysscher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Harry Groen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.