Phase II Trial of Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost for Treatment of Brain Metastases
- Zale Lipshy University Hospital
in this phase ii study, we plan to treat patients with brain metastases with WBRT-Ha/SiB. To assess the utility of WBRT-Ha/SiB, a comparison of these endpoints with historical data of WBRT without hippocampal avoidance will be necessary to determine whether a phase iii prospective randomized trial of WBRT with and without hippocampal avoidance would be warranted, and if so, what statistical considerations would be needed. We plan to utilize data from the control arm (WBRT alone) of a recent phase iii trial (PCi-P120-9801) of motexafin gadolinium and WBRT (30 Gy/10 fractions) versus WBRT alone in 401 patients with brain metastasis (Pi: Mehta) (Mehta 2003; Mehta 2002). These phase iii data serve as a particularly useful control for our phase ii study, given the similarities in inclusion criteria and study design
* Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy.. Direct biopsy of CNS lesions is not necessarily required although could constitute an allowed site of tissue confirmation as medically prudent. Patients who have been disease free for more than 5 years prior to the appearance of CNS metastases should undergo repeat biopsy of either a systemic metastasis or the CNS metastases to confirm the recurrent malignancy.
* Patients with measurable brain metastasis outside a 5-mm margin around either hippocampus
* Patients with measurable brain metastasis who have not been or will not be treated with SRS or surgical resection (Note: These treatment options are only permitted at relapse)
* History/physical examination within 28 days prior to registration
* Patients must fall into RTOG recursive partitioning analysis (RPA) class I or II
* Patients must have a life expectancy of at least 3 months.
* Age >= 18 years
* Karnofsky performance status >= 70
* Patients must provide study-specific informed consent prior to study entry
* Women of childbearing potential and male participants must practice adequate contraception
* Women of childbearing potential must have a negative, qualitative serum pregnancy test <=2 weeks prior to study entry
- Patients with progressive brain metastases beyond a brain lesion previously treated with radiosurgery are eligible so long as at least 3 months has transpired from the radiosurgery procedure prior to registration.