Comparing two radiation therapies for brain metastases in small-cell lung cancer

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)

This study is testing whether two types of targeted radiation therapy can be better options than standard whole brain radiation for people with small-cell lung cancer that has spread to the brain.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 340 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06457906 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the effectiveness of stereotactic radiosurgery (SRS) and hypofractionated radiotherapy (Hypo-RT) against whole brain radiation therapy (WBRT) that spares the hippocampus in patients with small-cell lung cancer (SCLC) that has metastasized to the brain. The study aims to determine if SRS/SRT/Hypo-RT can serve as a standard upfront treatment for patients with no more than 10 brain metastases. Eligible participants will be randomly assigned to receive either the local treatment or the hippocampus-avoiding WBRT. The trial focuses on minimizing neurological toxicity while effectively treating brain metastases.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with a confirmed diagnosis of small-cell lung cancer and no more than 10 brain metastases.

Not a fit: Patients with more than 10 brain metastases or those with a poor performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and less harmful treatment option for patients with brain metastases from small-cell lung cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison is novel.

Eligibility criteria

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;

Where this trial is running

Beijing, Beijing Municipality

• Nan Bi — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Nan Bi, M.D

Conditions: Small-cell Lung Cancer, Brain Metastases, SRS, Stereotactic Radiotherapy, Whole Brain Radiotherpay, Hippocampal-avoidance, Stereotactic radiotherapy, Whole brain radiotherpay