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NCT Number: NCT01282437

Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VU Medical Center, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic Cranial Irradiation

Radiation
  • 18 fractions of 2Gy
  • 12 fractions of 2.5Gy
  • 10 fractions of 3 Gy

Primary outcomes

  1. Proportion of patients developing symptomatic brain metastasis

    Time frame: 24 months after randomisation

Secondary outcomes

  1. Time to develop neurological symptoms (confirmed or unconfirmed by imaging)

    Time frame: 24 months after randomisation

  2. Measurement of side effects (CTCAE3.0)

    Time frame: 24 months after randomisation

  3. Quality of Life

    Time frame: 24 months after randomisation

    Measured by QLQ-C30 and EuroQol 5D

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • The Netherlands Cancer Institute
  • University Medical Center Groningen

Registry information

Official study 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: NVALT11

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Jan 25, 2011
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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