Clinical trial NCT00328575: Using Intensity Modulated Radiation Therapy (IMRT) for Brain Metastases
Official title: Phase I Dose Escalation Trial in Patients With Brain Metastases Using IMRT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm Metastasis
Keywords: Brain metastases
Parenchymal
Neoplasm
IMRT
Intensity Modulated Radiation Therapy
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2006-05-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if using intensity modulated radiation therapy for brain metastases is safe and will improve local control more than standard whole brain radiation therapy.

Detailed description: Traditionally, whole brain radiation therapy (WBRT) has been the primary therapy for patients with brain metastases. Despite this therapy, patients still have poor survival of four to six months. Untreated patients have a median survival of one month. Up to one half of these patients die of causes related to the presence of brain metastases. In a Phase I/II RTOG trial, the efficacy and safety of delivering accelerated fractionation was investigated in patients with good prognostic factors. No toxicity was observed with escalating dose of irradiation up 70.40Gy in 1.6Gy twice daily treatments. However, in a randomized trial, the use of hyperfractionation did not appear to improve survival when compared to 30Gy whole brain irradiation delivered in 10 fractions.

Current therapeutic approach also includes stereotactic radiosurgery (SRS). Several retrospective studies have demonstrated improved local tumor control of 80% with addition of SRS to WBRT. These local control rates were comparable to surgery. In a recently published randomized trial by RTOG 95-08 (TJU accrued 42 patients to this trial), Andrews et al. demonstrated improved survival in patients with solitary brain lesion treated with SRS. Median survival was 6.5 months in patients treated with WBRT and SRS compared to 4.9 months in patients treated with WBRT alone. Also, these patients were more likely to have stable or improved performance status.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed malignancy
* 2-5 parenchymal brain metastases on magnetic resonance imaging (MRI) with a maximum size of 4 cm
* Partial resection allowed. Complete resection allowed only in patients with more than 3 lesions.
* Karnofsky Performance Status (KPS) equal to or greater than 60
* Neurologic function equal to or greater than 2

Exclusion Criteria:

* Recurrent brain tumors
* Major medical or psychiatric illnesses
* Metastases in brainstem, midbrain, pons, or medulla
* Patients with leukemia or lymphoma

Primary outcomes:
measure: Unacceptable Acute CNS Toxicity
timeFrame: 3 weeks
Secondary outcomes:
measure: Dose-Limiting Toxicity (DLT)
timeFrame: 30 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Wenyin Shi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: