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Prophylactic Cranial Irradiation with or without hippocampal avoidance in SCLC: a randomized phase III study

Prophylactic Cranial Irradiation with or without hippocampal avoidance in SCLC: a randomized phase III study - HA-PCI

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45142
Enrollment
125
Registered
2013-02-27
Start date
2013-04-17
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitieve functies memory function small cell lung cancer

Interventions

Patient will receive prophylactic brain irradiation in 10 fractions

Sponsors

Nederlands Kanker Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * SCLC patients (stage I-III or stage IV without clinical or radiological evidence of brain metastases) candidate for PCI, i.e. without progressive disease after chemo-radiotherapy in stage I-III or after a remission after chemotherapy in stage IV * WHO-performance status * 2(see Appendix IV). * Sufficient proficiency in Dutch language * Written informed consent must be given according to ICH/GCP, national and local regulations

Exclusion criteria

Exclusion criteria: * Prior radiotherapy to the brain * clinical evidenceof brain metastases or primary brain tumors * Evidence of progressive extracranial metastatic disease * Previous malignancy

Design outcomes

Primary

MeasureTime frame
To assess memory function at 4 months after PCI versus HA-PCI. A decline of 5 points in the total recall score will be considered as a failure.

Secondary

MeasureTime frame
* To assess early and late neurotoxicity and quality of life following PCI with or without hippocampal sparing. * To assess structural brain damage from PCI on MRI with and without sparing of the hippocampus. * To assess the incidence and location of brain metastases after PCI with or without hippocampal sparing. * Overall survival.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)