Recruiting

IMRT & Conventional Radiation

Sponsor:

Good Samaritan Hospital Medical Center, New York

Code:

NCT01890278

Conditions

Metastatic Brain Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Whole Brain IMRT

Conventional Whole Brain RT

Study Details

Brief summary:

In this study the patient will receive either whole brain radiation therapy given by intensity modulated radiation therapy (IMRT) or standard conventional radiation. In IMRT therapy radiation dose to the parts of the brain that do not contain tumors is reduced. This study will look to see if this approach results in less hair loss or fewer memory Problems, as compared to the standard technique. The study will also look at the effectiveness of both techniques in controlling the growth of the tumor.

Conditions

Metastatic Brain Cancer

Study ID

NCT01890278

Start date

Jun, 2013

Status verified date

Jun, 2013

Completion date

Mar, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

ELIGIBILITY CHECKLIST

Inclusion Criteria:

  • Evidence of at least one brain metastasis on a gadolinium contrast-enhanced MRI
  • Pathologic/histological/cytologic proof of a diagnosis of a non-hematopoietic malignancy within 5 years of study entry.
  • Patient ≥18 years of age?
  • Fall into RTOG Recursive Partition Analysis (RPA) class I or II.
  • Karnofsky Performance Score ≥70. (See Appendix III)
  • Biopsy done at least 1 week prior to registration. (This requirement does not apply to stereotactic biopsies.)

Exclusion Criteria:

  • Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia.
  • Creatinine level > 1.4 mg/dl drawn ≤30 days prior to study entry.
  • Severe, active co-morbitities.
  • Unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months.
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Uncontrolled, clinically significant cardiac arrhythmias
  • Pregnancy

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Whole Brain IMRT

Whole brain radiation therapy delivered via IMRT (37.5 Gy to brain tumor, 30 Gy to the uninvolved brain in 15 fractions), mean dose of less than 18 Gy to scalp.

active comparator: Conventional whole brain RT

Conventional whole brain radiation therapy (37.5 Gy to the brain tumors and uninvolved brain in 15 fractions).

Interventions

Whole Brain IMRT

Conventional Whole Brain RT

Primary outcome measure

  • Alopecia [ Time Frame: 1 to 4 months after radiation ]

Central Contacts and Locations

Central contacts

Johnny Kao, MD

631-376-4047johnny.kao@chsli.org

Linda M Reuter

631-376-3093linda.reuter@chsli.org

Locations

Good Samaritan Hospital Medical Center

Recruiting

West Islip, New York, United States, 11795

Contacts

Johnny Kao, MD

631-376-4047johnny.kao@chsli.org

Principal Investigator:

Johnny Kao, MD

More Information

Sponsor

Good Samaritan Hospital Medical Center, New York

Last update posted

Jul 1, 2013

Last verified

Jun, 2013

Keywords

  • Brain Cancer
  • Metastatic Brain Cancer
  • IMRT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Good Samaritan Hospital Medical Center, New York on 2013-07-01.