Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457906
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
SRSSRTHypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
SRSSRTHypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in Patients With Small-Cell Lung Cancer A Prospective Randomized Multicenter Phase III Trial SHARP Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHARP
Brief Summary:
This phase III trial compares the effect of stereotactic radiosurgery and whole brain radiation therapy that avoids the hippocampus the memory zone of the brain for the treatment of small cell lung cancer that has spread to the brain
Detailed Description:
Small cell lung cancer SCLC is the most aggressive histologic subtype of lung cancer with a predilection for early metastases Brain metastases BM are a significant threat to quality of life in patients with SCLC Stereotactic radiosurgery SRS Stereotactic Radiotherapy SRT is a specialized radiation therapy that delivers a single high dose of radiation directly to the tumor and may cause less damage to the surrounding normal tissue Thus SRSSRT has now emerged as the preferred treatment modality either alone or in combination with other modalities for BM However given the propensity for dissemination of SCLC SRSSRT does not appear to be a rational approach to this pathology Recently in selected patients whole brain radiotherapy WBRT has been omitted from the initial management for BM with the aim of reducing the potential risk of delayed neurological toxicity1-3 Thus the role of upfront focal treatment by means of SRS for BM from SCLC has yet to be determined
This phase III trial compares the effect of upfront local treatment including SRSSRT and hypofractionated radiotherapy Hypo-RT and WBRT that avoids the hippocampus the memory zone of the brain for the treatment of no more than 10 BM in SCLC patients The expectation is that SRSSRTHypo-RT will be one of standard upfront local treatments in SCLC patients with no more than 10 BM
Eligible patients will be 11 randomized to receive ether local treatment SRSSRTHypo-RT or hippocampal-voidance WBRT The prescription dose of SRSSRT is 18-22Gy in 1 fraction 27Gy in 3 fractions and 30Gy in 5 fractions The prescription dose of Hypo-RT is 40Gy in 8 fraction The prescription dose of HA-WBRT is 30Gy in 10 fraction The prescription dose could be adjusted if lesions are located in brain stem when treat with SRSSRTHypo-RT
This phase III trial compares the effect of upfront local treatment including SRSSRT and hypofractionated radiotherapy Hypo-RT and WBRT that avoids the hippocampus the memory zone of the brain for the treatment of no more than 10 BM in SCLC patients The expectation is that SRSSRTHypo-RT will be one of standard upfront local treatments in SCLC patients with no more than 10 BM
Eligible patients will be 11 randomized to receive ether local treatment SRSSRTHypo-RT or hippocampal-voidance WBRT The prescription dose of SRSSRT is 18-22Gy in 1 fraction 27Gy in 3 fractions and 30Gy in 5 fractions The prescription dose of Hypo-RT is 40Gy in 8 fraction The prescription dose of HA-WBRT is 30Gy in 10 fraction The prescription dose could be adjusted if lesions are located in brain stem when treat with SRSSRTHypo-RT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None