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Phase I Dose Escalation Trial in Patients With Brain Metastases Using IMRT

Phase 1
18 Years
Not Enrolling
Neoplasm Metastasis

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Trial Information

Phase I Dose Escalation Trial in Patients With Brain Metastases Using IMRT

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Unacceptable Acute CNS Toxicity

Outcome Description:

The primary endpoint is the frequency of patients developing unacceptable acute CNS toxicity.

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

Wenyin Shi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Institutional Review Board

Study ID:




Start Date:

October 2005

Completion Date:

June 2011

Related Keywords:

  • Neoplasm Metastasis
  • Brain metastases
  • Parenchymal
  • Neoplasm
  • IMRT
  • Intensity Modulated Radiation Therapy
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms



Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541