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Phase I Study of Whole Brain Radiation Therapy With Simultaneous Boost to Gross Metastatic Tumor Volume Using Volumetric Modulated Arc Therapy (VMAT)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasm Metastasis

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Trial Information

Phase I Study of Whole Brain Radiation Therapy With Simultaneous Boost to Gross Metastatic Tumor Volume Using Volumetric Modulated Arc Therapy (VMAT)


Inclusion Criteria:



- Pathologic proven diagnosis of solid tumor malignancy.

- Age ≥ 18.

- KPS ≥ 70.

- Mini Mental Status Exam (MMSE) ≥ 18 prior to study entry.

- RPA class I (KPS≥70, primary cancer controlled, age<65, metastases in brain only) or
class II (lack of one or more of class I criteria)

- One to ten brain metastatic lesions.

Exclusion Criteria:

- Previous whole brain radiation therapy

- Previous radiosurgery to any currently progressive gross metastatic disease

- Previous radiosurgery to any intracranial site within the prior 6 weeks

- RPA class III

- Radiosensitive (eg. small cell lung carcinomas, germ cell tumors, leukemias, or
lymphomas) or unknown tumor histologies.

- Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation).

- Evidence of leptomeningeal disease by MRI and/or CSF cytology.

- Current pregnancy

- No metastases to brain stem, midbrain, pons, or medulla or within 7 mm of the optic
apparatus (optic nerves and chiasm).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Outcome Description:

The MTD will be defined as either the dose when a grade 3 or greater toxicity judged to be at least possibly due to the treatment develops in 2 of 6 patients in a dose group within 3 months of the treatment or the highest dose level (group 3) if < 2 of 6 patients develop a grade 3 or greater toxicity judged to be at least possibly due to the treatment at that dose within 3 months of treatment. If > 2 of 6 patients develop a grade 3 or greater toxicity at a dose level, the dose is de-escalated to the prior group and that group is expanded to 6 patients.

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Hui-Kuo Shu, MD Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University

Authority:

United States: Institutional Review Board

Study ID:

WBRT-RA-2010

NCT ID:

NCT01218542

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Neoplasm Metastasis
  • Secondary brain malignancies
  • RapidArc
  • Volumetric modulated arc therapy
  • Neoplasms
  • Neoplasm Metastasis

Name

Location
Emory University Winship Cancer Institute Atlanta, Georgia  30322
Emory University Hospital Midtown Atlanta, Georgia  30308