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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01282437
Other study ID # NVALT11
Secondary ID
Status Completed
Phase Phase 3
First received January 24, 2011
Last updated April 9, 2015
Start date January 2009
Est. completion date March 2015

Study information

Verified date April 2015
Source Maastricht Radiation Oncology
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 315
Est. completion date March 2015
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Radiation:
Prophylactic Cranial Irradiation
18 fractions of 2Gy 12 fractions of 2.5Gy 10 fractions of 3 Gy

Locations

Country Name City State
Netherlands The Netherlands Cancer Institute Amsterdam
Netherlands VU Medical Center Amsterdam
Netherlands RT Insitute Stedendriehoek Deventer
Netherlands UMCG Groningen Groningen
Netherlands Maastro Clinic Maastricht Limburg
Netherlands St. Antonius Ziekenhuis Nieuwegein
Netherlands Dr. Bernard Verbeeten Institute Tilburg
Netherlands UMC Utrecht Utrecht
Netherlands Isala Klinieken Zwolle

Sponsors (3)

Lead Sponsor Collaborator
Maastricht Radiation Oncology The Netherlands Cancer Institute, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients developing symptomatic brain metastasis 24 months after randomisation No
Secondary Time to develop neurological symptoms (confirmed or unconfirmed by imaging) 24 months after randomisation No
Secondary Measurement of side effects (CTCAE3.0) 24 months after randomisation Yes
Secondary Quality of Life Measured by QLQ-C30 and EuroQol 5D 24 months after randomisation No
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