Trials / Recruiting
RecruitingNCT06457906
SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC
SRS/SRT/Hypo-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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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 SRS/SRT 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, SRS/SRT 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 toxicity\[1-3\]. 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 SRS/SRT 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 SRS/SRT/Hypo-RT will be one of standard upfront local treatments in SCLC patients with no more than 10 BM. Eligible patients will be 1:1 randomized to receive ether local treatment (SRS/SRT/Hypo-RT), or hippocampal-voidance WBRT. The prescription dose of SRS/SRT 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 SRS/SRT/Hypo-RT.
Conditions
- Small-cell Lung Cancer
- Brain Metastases
- SRS
- Stereotactic Radiotherapy
- Whole Brain Radiotherpay
- Hippocampal-avoidance
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Experimental group (SRS/SRT/Hypo-RT) | The prescription dose of SRS/SRT 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 could be adjusted if lesions are located in brain stem when treat with SRS/SRT/Hypo-RT. |
| RADIATION | Controled group (HA-WBRT) | The prescription dose of HA-WBRT is 30Gy in 10 fraction. |
Timeline
- Start date
- 2023-09-01
- Primary completion
- 2027-08-30
- Completion
- 2028-02-28
- First posted
- 2024-06-13
- Last updated
- 2025-07-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06457906. Inclusion in this directory is not an endorsement.