Phase II Trial of Conventional Versus IMRT Whole Brain Radiotherapy for Brain Metastases

NCT01890278 | Unknown

• 1 other identifier: 12-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Brain Cancer; Metastatic Brain Cancer; IMRT

Outcome Measures

Primary Outcomes (1)

• Alopecia

  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.

  1 to 4 months after radiation

Secondary Outcomes (2)

• The study will also look at the effectiveness of both techniques in controlling the growth of the tumor.

  1 year

• Quality of life

  1 year after radiation

Study Arms (2)

Whole Brain IMRT

ACTIVE COMPARATOR

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.

Radiation: Whole Brain IMRT

Conventional whole brain RT

ACTIVE COMPARATOR

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

Radiation: Conventional Whole Brain RT

Interventions

Whole Brain IMRT RADIATION

Whole Brain IMRT

Conventional Whole Brain RT RADIATION

Conventional whole brain RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Good Samaritan Hospital Medical Center, New York: lead

Study Sites (1)

Good Samaritan Hospital Medical Center

West Islip, New York, 11795, United States

RECRUITING

Related Publications (38)

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MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Johnny Kao, MD

  Good Samaritan Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johnny Kao, MD

CONTACT

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

Linda M Reuter

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: July 1, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 1, 2013

Record last verified: 2013-06

Locations

US (1)