Neoplasm Metastasis Clinical Trial
Official title:
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03775980 -
CIRSE Emprint Microwave Ablation Registry
|
||
Completed |
NCT01114958 -
Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases
|
Phase 1 | |
Terminated |
NCT03986593 -
Cryoablation of Bone Metastases From Endocrine Tumors
|
N/A | |
Active, not recruiting |
NCT04458259 -
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
|
Phase 1 | |
Not yet recruiting |
NCT03175146 -
A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely
|
N/A | |
Active, not recruiting |
NCT02395224 -
A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway
|
||
Completed |
NCT02374411 -
Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
|
N/A | |
Recruiting |
NCT01960829 -
Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study
|
Phase 2 | |
Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
Terminated |
NCT01846429 -
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
|
Phase 1 | |
Recruiting |
NCT01564810 -
Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer
|
Phase 4 | |
Completed |
NCT00375245 -
Rapamycin With Grapefruit Juice for Advanced Malignancies
|
Phase 1 | |
Completed |
NCT00207116 -
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma
|
Phase 1 | |
Completed |
NCT00232726 -
Clinical Study of Previously Untreated Patients With Malignant Melanoma
|
Phase 2 | |
Completed |
NCT00207103 -
MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT00172003 -
Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
|
Phase 4 | |
Completed |
NCT00094003 -
Study of NS-9 in Patients With Liver Metastases
|
Phase 1 |