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

Phase 3

Recruiting

Conditions: cognitieve functies
memory function
small cell lung cancer
10038666

Registration Number: NL-OMON45142

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 125

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

* Prior radiotherapy to the brain
* clinical evidenceof brain metastases or primary brain tumors
* Evidence of progressive extracranial metastatic disease
* Previous malignancy < 2 years ago except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
* Any systemic anticancer treatment during PCI or within 3 weeks before start PCI.
* Pregnancy or lactation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess memory function at 4 months after PCI versus HA-PCI. A decline of 5<br /><br>points in the total recall score will be considered as a failure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* To assess early and late neurotoxicity and quality of life following PCI with<br /><br>or without hippocampal sparing.<br /><br>* To assess structural brain damage from PCI on MRI with and without sparing of<br /><br>the hippocampus.<br /><br>* To assess the incidence and location of brain metastases after PCI with or<br /><br>without hippocampal sparing.<br /><br>* Overall survival.</p><br>