Trials / Completed
CompletedNCT01282437
Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC
Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 315 (actual)
- Sponsor
- Maastricht Radiation Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Prophylactic Cranial Irradiation | * 18 fractions of 2Gy * 12 fractions of 2.5Gy * 10 fractions of 3 Gy |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2014-09-01
- Completion
- 2015-03-01
- First posted
- 2011-01-25
- Last updated
- 2015-04-10
Locations
9 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01282437. Inclusion in this directory is not an endorsement.