Clinical trial · Interventional
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)
NCT06457906CI-TRIAL-00092188SHARPrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Hippocampal-avoidance | — | UNRESOLVED | — |
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| SRS | — | UNRESOLVED | — |
| Stereotactic Radiotherapy | — | UNRESOLVED | — |
| Whole Brain Radiotherpay | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Controled group (HA-WBRT) | Radiation | — | UNRESOLVED |
| Experimental group (SRS/SRT/Hypo-RT) | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SRS/SRT/Hypo-RT group
- description
- The patients in this group will receive local treatment for BM.
- interventionNames
- Combination Product: Experimental group (SRS/SRT/Hypo-RT)
- type
- ACTIVE_COMPARATOR
- label
- HA-WBRT group
- description
- The patients in this group will receive HA-WBRT.
- interventionNames
- Radiation: Controled group (HA-WBRT)
Primary outcomes (2)
- measure
- Cognitive function scores
- timeFrame
- At 6 months after radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Investigators should consider these factors when selecting patients for this trial. Investigators also should consider all other relevant factors (medical and non-medical), as well as the risks and benefits of the study therapy, when deciding if a patient is an appropriate candidate for this trial. 1. Adult patients (18-80 years of age) with Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance score ≥ 70, expected life time more than 6 months; 2. Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis). Patients with de novo or recurrent small cell lung cancer are permitted; 3. No more than 10 metastatic brain lesions with ≤5 cm in largest diameter and ≤150 ml in treated volume, confirmed by a high-resolution (thickness ≤2mm) , 3-dimensional T1-weighted postgadolinium magnetic resonance imaging (MRI) brain scan within 2 weeks of study initiation. All brain metastases must be outside a 5-mm margin around either hippocampus or optic pathways. 4. Not all metastatic brain lesions are recommended or suitable for surgical resection after multidisciplinary team discussion. If part of metastatic brain lesions are resected, the patient is permitted for enrollment evaluation at least two weeks after resection; 5 Patients must have the psychological ability and general health that permits completion of the study requirements, all assessment (HVLT-R, MoCA, EORTC QLQ-C30) and required follow up (at least 6 months); 6\. At least one measurable BM according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria; 7. Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during treatment on this study and for up to 180 days after completion of all treatment to prevent pregnancy or fathering a child; 8. Written informed consent (must be available before enrolment in the trial). Exclusion Criteria: 1. Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration; 2. Previous radiotherapy of the brain; 3. Patients can not tolerate immobilization or are with MRI contraindication (i.e., cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants); 4. Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases, increased intracranial pressure requiring immediate depression surgery. 5. Patients who have not yet recovered from acute high-grade (≥Grade 3) toxicities of prior therapies according Common Terminology Criteria for Adverse EventsVersion5.0 (CTC 5.0); 6. Presence of other serious illnesses such as acute myocardial infarction, severe arrhythmia, or psychiatric disorders within the past 6 months; 7. Known carcinoma \< 5 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy; 8. Pregnant or lactating women; 9. Participation in another clinical study or observation period of competing trials, respectively;
References
Publications (3)
- BACKGROUNDYomo S, Hayashi M. Upfront stereotactic radiosurgery in patients with brain metastases from small cell lung cancer: retrospective analysis of 41 patients. Radiat Oncol. 2014 Jul 8;9:152. doi: 10.1186/1748-717X-9-152. PMID 25005424
- BACKGROUNDRusthoven CG, Yamamoto M, Bernhardt D, Smith DE, Gao D, Serizawa T, Yomo S, Aiyama H, Higuchi Y, Shuto T, Akabane A, Sato Y, Niranjan A, Faramand AM, Lunsford LD, McInerney J, Tuanquin LC, Zacharia BE, Chiang V, Singh C, Yu JB, Braunstein S, Mathieu D, Touchette CJ, Lee CC, Yang HC, Aizer AA, Cagney DN, Chan MD, Kondziolka D, Bernstein K, Silverman JS, Grills IS, Siddiqui ZA, Yuan JC, Sheehan JP, Cordeiro D, Nosaki K, Seto T, Deibert CP, Verma V, Day S, Halasz LM, Warnick RE, Trifiletti DM, Palmer JD, Attia A, Li B, Cifarelli CP, Brown PD, Vargo JA, Combs SE, Kessel KA, Rieken S, Patel S, Guckenberger M, Andratschke N, Kavanagh BD, Robin TP. Evaluation of First-line Radiosurgery vs Whole-Brain Radiotherapy for Small Cell Lung Cancer Brain Metastases: The FIRE-SCLC Cohort Study. JAMA Oncol. 2020 Jul 1;6(7):1028-1037. doi: 10.1001/jamaoncol.2020.1271. PMID 32496550
- BACKGROUNDRobin TP, Jones BL, Amini A, Koshy M, Gaspar LE, Liu AK, Nath SK, Kavanagh BD, Camidge DR, Rusthoven CG. Radiosurgery alone is associated with favorable outcomes for brain metastases from small-cell lung cancer. Lung Cancer. 2018 Jun;120:88-90. doi: 10.1016/j.lungcan.2018.03.027. Epub 2018 Apr 2. PMID 29748022