|- candidate number||4809|
|- NTR Number||NTR1601|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-dec-2008|
|- Secondary IDs||08-3-049 MEC |
|- Public Title||Prophylactic Cranial Irradiation (PCI) versus observation in radically treated patients with stage III non-small cell lung cancer: A phase III randomized study.|
|- Scientific Title||Prophylactic Cranial Irradiation (PCI) versus observation in radically treated patients with stage III non-small cell lung cancer: A phase III randomized study.|
|- ACRONYM||NVALT-11 study/DLCRG-02 study|
|- hypothesis||PCI will prevent brain metastases, even for patients with other sites of failure, and will improve the neurological disease-free survival, and hence quality of life. PCI will also be cost-effective.|
|- Healt Condition(s) or Problem(s) studied||Non small cell lung cancer (NSCLC)|
|- Inclusion criteria||Registration: |
1. UICC stage III A or IIIB (without malignant pleural or pericardial effusion) non-small cell lung cancer (histology or cytology);
2. Whole body FDG-PET-scan before the start of therapy available: No distant metastases;
3. CT or MRI of the brain before the start of therapy available: No brain metastases;
4. No other malignancy in the preceding 2 years, except non-melanoma skin cancer or any carcinoma in situ;
5. No prior cranial irradiation;
6 Patient should be suitable for radical treatment with Platinum-based chemotherapy and is planned to receive radical loco-regional therapy: concurrent or sequential chemotherapy (Platinum-based) and radiotherapy with or without surgery (Radiotherapy dose without surgery at least a biological equivalent of 60 Gy (20));
7. Patients must sign a study-specific informed consent at the time of registration. At the same time, thus before randomization, the baseline forms (CTCAE3.0, QLQ-C30 and EuroQol 5D) should be filled out.
1. Patient has been registered in the study and has completed appropriate radical treatment, no more than 6 weeks before. Registration is thus allowed either before or after radical therapy;
2. The patient is ready to receive PCI within 1 week of randomization (if randomized to PCI arm);
3. There is no clinical evidence of progressive disease after chemo-radiation (no imaging is requested);
4. No evidence of extracranial distant metastatic disease;
5. Signed informed consent for randomization.
|- Exclusion criteria||Registration:|
1. Pregnant women are ineligible as treatment involves unforeseen risks to the participant and to the embryo or fetus;
patients with childbearing potential must practice appropriate contraception.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-sep-2008|
|- planned closingdate||16-sep-2013|
|- Target number of participants||300|
|- Interventions||Arm 1: 36 Gy in 18 fractions, 30 Gy in 12 fractions or 30 Gy in 10 fractions.|
Arm 2: observation.
|- Primary outcome||To determine whether PCI decreases the proportion of patients developing symptomatic brain metastases in patients with radically treated stage III NSCLC.|
Symptomatic brain metastases are defined as a combination of at least key symptom suggesting brain metastases (signs of increased intracranial pressure, headache, nausea and vomiting, cognitive or affective disturbances, seizures and focal neurological symptoms) and MRI or CT proving the existence of brain metastasis.
|- Secondary outcome||1. To determine the time to develop neurological symptoms (confirmed or unconfirmed by imaging);|
2. To determine the side effects and effects on the general condition of PCI with the CTCAE 3.0 scoring system, assessed by the patient;
3. To determine the Quality of Life (QoL) (QLQ-C30 and EuroQol 5D);
4. To determine the effect of PCI on the overall survival;
5. To find out whether PCI is cost-effective as opposed to observation in this setting. This part of the study will only be performed in Maastricht.
|- Timepoints||The inclusion period therefore will be about 36 months. In order to obtain reliable two-year data, another 2 years of follow-up will be necessary.|
Patients will be followed up to at least 36 months after randomization.
|- Trial web site||www.nvalt-oncology.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| D.J. Storm|
|- CONTACT for SCIENTIFIC QUERIES||Dr D. Ruysscher, de |
|- Sponsor/Initiator ||NVALT Oncology, DLCRG|
(Source(s) of Monetary or Material Support)
|NVALT Oncology, DLCRG|
|- Brief summary||In summary, there is compelling evidence that PCI to a dose comparable with that used in SCLC also reduces the incidence of brain metastases in patients with locally advanced NSCLC. |
Major reasons why in contrast to small-cell lung cancer, PCI has not been accepted as standard treatment in stage III NSCLC, are 1. that in none of the randomized studies contemporary chemotherapy was used;
2. in most trials the local radiation treatment was below present standards;
3. the staging of these patients was in all but one (16) study outdated;
4. the reduction of brain metastases does not represent a meaningful endpoint as such for the patient.
Apart from disease- or symptom-free survival and overall survival data, the measurement of toxicity and quality of life in the current treatment setting is needed.
The aim of the present phase III study is therefore to investigate whether PCI also affects the afore-mentioned patient-related endpoints.
|- Main changes (audit trail)|
|- RECORD||23-dec-2008 - 10-feb-2009|