2026-08-12
critical
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v3
Primary endpoint(s) modified2 to 4 entries
WasCOHORT A-assess safety of addition of PULSAR radiotherapy to thoracic tumor in ES-SCLC alongside chemoimmunotherapy, while making preliminary/exploratory assessments of disease response and dosimetric benefit to PULSAR, COHORT B-assesses ability to de-escalate dose in good responders by imaging using rule-based imaging-response guided omission of 2nd "pulse" of PULSAR fractionated SRS (fSRS) for brain metastases
NowCOHORT A-assess safety of addition of PULSAR radiotherapy to thoracic tumor in ES-SCLC alongside chemoimmunotherapy, while making preliminary/exploratory assessments of disease response and dosimetric benefit to PULSAR, COHORT B-assesses ability to de-escalate dose in good responders by imaging using rule-based imaging-response guided omission of 2nd "pulse" of PULSAR fractionated SRS (fSRS) for brain metastases, COHORT C- assess the rate of MWC in a novel approach of immunotherapy with concurrent PULSAR., COHORT D-assess the proportion of patients who proceed to curative intent resection following neoadjuvant therapy.
Enrollment increased: 45 → 105 participants
Trial arms changed: 2 → 4
Primary completion pushed: 2028-09-01 → 2030-09-01
Completion pushed: 2030-09-01 → 2032-09-01
InterventionsCohort A: Extensive Stage Small Cell Lung Cancer (ES-SCLC) Thoracic Tumor PULSAR (Personalized ultrahypofractionated stereotactic ablative…→Cohort A: Extensive Stage Small Cell Lung Cancer (ES-SCLC) Thoracic Tumor PULSAR (Personalized ultrahypofractionated stereotactic ablative…
Eligibility criteria+1,118 characters
[...] tumor malignancy with MRI-defined brain metastasis lesions (1-5 lesions allowed) within 60 days of registration
Each brain metastasis lesion [...] m, except brainstem lesions which may be 1.5 - 5cm in size.
Cohort C:
>=18 years old
Performance status ECOG 0-2
Histologically confirmed surgically resectable, high grade (FNCLCC grade 2 or 3), localized soft tissue sarcoma of the trunk or extremities that measures >5 cm in any direction as assessed by imaging
Eligible to receive immunotherapy
Cohort D:
>=1 [...] Exclusion Criteria:
Cohort A:
⨀ Prior thoracic Radiotherapy
[...] otherapy of a target brain metastasis
[...]
Study description+3,894 characters
[...] pulse" for "responders," while retaining high control rates.
COHORT C (Pre-op Sarcoma PULSAR):
Pre-operative radiotherapy is an integral component of treatment for large (>5cm), high grade, extremity and trunk soft tissue sarcomas.
Recent developments in this disease include the use of preoperative stereotactic body radiotherapy (SBRT) and the addition of co [...]
2025-11-06
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-10-15→confirmed 2025-10-28
Study sites0→1