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| ID | Type | Description | Link |
|---|---|---|---|
| IEC/3470 | Other Identifier | Tata Memorial Hospital |
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Tyrosine Kinase Inhibitors (TKIs) especially higher generation TKI have higher CNS penetration rates and have shown favorable response rates in brain metastases. Brain radiotherapy/surgery is the standard treatment in brain metastases especially symptomatic metastases, however, the role of local treatment especially in driver mutation-positive non-small cell lung cancer with asymptomatic brain metastases is being questioned given their potential side effects. No randomized trial has shown the superiority of early vs delayed cranial RT in asymptomatic BM of driver mutated NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upfront Cranial Radiotherapy | Active Comparator | Stereotactic radiosurgery or Whole brain radiotherapy upfront in asymptomatic brain metastases |
|
| Observation (Delayed Cranial Radiotherapy) | Experimental | Observation (Delayed Cranial radiotherapy) of Asymptomatic brain metastases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic radiosurgery/whole brain radiotherapy | Radiation | SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial progression free survival at 24 months | Intracranial progression free survival will be defined as the time from the date of randomization until the date of intracranial progression is documented. Death without intracranial progression will be considered as a competing event. Intracranial response will be graded as per the Response Assessment in Neuro-Oncology (RANO) guidelines for brain metastases | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival will be defined as the time from randomization until the date of death from any cause in the presence or absence of recurrence. | Upto 5-year |
| Progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anil Tibdewal, MD | Contact | 9122 2417 7000 | 7030 | aniltibdewal@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tata Memorial Hospital | Recruiting | Mumbai | Maharashtra | 400012 | India |
Protocol manuscript will be published and the results will be published in international peer-reviewed journal
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| Tyrosine kinase inhibitor | Drug | TKI |
|
Progression free survival will be defined from the date of randomization to the date of progression or the date of death whichever is earlier.
| upto 2 year |
| Neurocognition toxicity | Neuro-cognition assessment will be done using HVLT-R (Total Recall) at baseline and at 3, 6 and 12 months for assessable patients | Upto 12 months |
| Toxicity using CTC v5.1 | Toxicity assessment will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years | Upto 2 years |
| Local Control | Upto 2 years |
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D000092004 | Tyrosine Kinase Inhibitors |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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