Study ID: NRG CC003
A randomized phase II/III trial of prophylactic cranial irradiation with or without hippocampal avoidance for small cell lung cancer
Researchers seek to determine how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in patients with small cell lung cancer (SCLC). The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking.
All patients in the study receive prophylactic cranial irradiation (PCI), which is a technique used to combat the occurrence of metastasis to the brain in highly aggressive cancers that commonly metastasize to the brain, most notably SCLC.
Eligible trial participants are randomized to one of the following two treatment arms:
- Arm 1: Patients undergo PCI daily for two weeks.
- Arm 2: Patients undergo PCI with hippocampal avoidance using intensity-modulated radiation therapy (IMRT) daily for two weeks. IMRT uses sophisticated imaging and software to identify the exact size, shape and location of a tumor and to deliver a precise dose of radiation that conforms to the tumor and leaves surrounding tissue intact.
After completion of study treatment, patients are followed every three months for one year, then every six months for three years, and then annually.
The primary objectives of this study are as follows:
- Determine whether the 12-month intracranial relapse rate following hippocampal avoidance (HA)-prophylactic cranial irradiation (PCI) is non-inferior compared to the rate following PCI for patients with SCLC.
- Determine whether HA-PCI reduces the likelihood of six-month deterioration from baseline in Hopkins Verbal Learning Test-revised delayed recall compared to PCI for patients with SCLC.
- Arm 1 (comparator): PCI alone (25 Gy in 10 fractions)
- Arm 2 (experimental): PCI with hippocampal avoidance using IMRT (25 Gy in 10 fractions)
Must have been diagnosed with small cell lung cancer