Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/3/2017 |
| Start Date: | April 2013 |
| End Date: | September 2018 |
| Contact: | Hui-Kuo G Shu, MD, PhD |
| Email: | hgshu@emory.edu |
| Phone: | 404-778-2161 |
Whole Brain Radiation Therapy With Simultaneous Boost to Gross Metastatic Tumor Volume Using Volumetric Modulated Arc Therapy (RapidArc)
Brain metastases are the most common adult intracranial tumor, occurring in approximately
10% to 30% of adult cancer patients, and represent an important cause of morbidity and
mortality. The most widely used treatment for patients with multiple brain metastases is
whole brain radiation therapy (WBRT). The use of WBRT after resection or stereotactic
radiosurgery (SRS) has been proven to be effective in terms of improving local control of
brain metastases.
RapidArc (RA) (Varian Medical Systems, Palo Alto, CA) is a new method of delivering
radiation that uses "arcs" to deliver highly conformal intensity modulated three dimensional
dose distributions. The purpose of this investigation is to evaluate an alternative strategy
for giving WBRT with highly focal boost to gross visible lesions in patients with brain
metastasis.
Given the limitations of the SRS boost technique, the purpose of our investigation is to
evaluate an alternative strategy for giving WBRT with highly focal boost to gross visible
lesions in patients with brain metastasis. In this study, we plan to assess the tolerability
of using volumetric modulated arc therapy (RapidArc) on patients with brain metastasis to
simultaneously treat the entire brain with a concomitant focal boost to grossly identified
lesions on MRI scan to try to improve local control and reduce neurocognitive toxicities.
This previous version of this study was a phase I dose escalation trial giving 25 Gy in 10
fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10
fractions to gross brain metastatic disease. Prior to this, patients were enrolled onto one
of two cohorts with whole brain dose of 30 Gy in 10 fractions with SIB to total of 45 Gy in
10 fractions to gross brain metastatic disease or whole brain dose of 37.5 Gy in 15
fractions with SIB to total of 52.5 Gy in 15 fractions to gross brain metastatic disease. A
total of 12 patients have been previously enrolled on this trial. No patients have
experienced a dose limiting toxicity (grade 3 or above) at least possibly due to study
therapy. Also, no patients experienced local brain failure/progression at a site of treated
metastatic brain disease. Based on this, we no longer feel that dose escalation to the gross
brain disease is warranted and would proceed with a single arm pilot study treating patients
with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a
total of 45 Gy in 10 fractions to gross brain metastatic disease.
10% to 30% of adult cancer patients, and represent an important cause of morbidity and
mortality. The most widely used treatment for patients with multiple brain metastases is
whole brain radiation therapy (WBRT). The use of WBRT after resection or stereotactic
radiosurgery (SRS) has been proven to be effective in terms of improving local control of
brain metastases.
RapidArc (RA) (Varian Medical Systems, Palo Alto, CA) is a new method of delivering
radiation that uses "arcs" to deliver highly conformal intensity modulated three dimensional
dose distributions. The purpose of this investigation is to evaluate an alternative strategy
for giving WBRT with highly focal boost to gross visible lesions in patients with brain
metastasis.
Given the limitations of the SRS boost technique, the purpose of our investigation is to
evaluate an alternative strategy for giving WBRT with highly focal boost to gross visible
lesions in patients with brain metastasis. In this study, we plan to assess the tolerability
of using volumetric modulated arc therapy (RapidArc) on patients with brain metastasis to
simultaneously treat the entire brain with a concomitant focal boost to grossly identified
lesions on MRI scan to try to improve local control and reduce neurocognitive toxicities.
This previous version of this study was a phase I dose escalation trial giving 25 Gy in 10
fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10
fractions to gross brain metastatic disease. Prior to this, patients were enrolled onto one
of two cohorts with whole brain dose of 30 Gy in 10 fractions with SIB to total of 45 Gy in
10 fractions to gross brain metastatic disease or whole brain dose of 37.5 Gy in 15
fractions with SIB to total of 52.5 Gy in 15 fractions to gross brain metastatic disease. A
total of 12 patients have been previously enrolled on this trial. No patients have
experienced a dose limiting toxicity (grade 3 or above) at least possibly due to study
therapy. Also, no patients experienced local brain failure/progression at a site of treated
metastatic brain disease. Based on this, we no longer feel that dose escalation to the gross
brain disease is warranted and would proceed with a single arm pilot study treating patients
with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a
total of 45 Gy in 10 fractions to gross brain metastatic disease.
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.
- Recursive partitioning analysis (RPA) class III (KPS < 70).
- 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 cerebrospinal fluid (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).
We found this trial at
2
sites
550 Peachtree St NE
Atlanta, Georgia 30308
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Pretesh Patel, MD
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, Georgia 30322
Principal Investigator: Hui-Kuo Shu, MD, PhD
Phone: 404-778-2161
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