NCT06457906

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P50-P75 for phase_3

Timeline
22mo left

Started Sep 2023

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Sep 2023Feb 2028

Study Start

First participant enrolled

September 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

June 10, 2024

Last Update Submit

July 12, 2025

Conditions

Small-cell Lung CancerBrain MetastasesSRSStereotactic RadiotherapyWhole Brain RadiotherpayHippocampal-avoidance

Keywords

Small-cell Lung CancerBrain MetastasesSRSStereotactic radiotherapyWhole brain radiotherpayHypofractionaed radiotherapyHippocampal-avoidance

Outcome Measures

Primary Outcomes (2)

  • Cognitive function scores

    Hopkins Verbal Learning Test-Revised (HVLT-R) total recall score at 6 months after radiotherapy

    At 6 months after radiotherapy.

  • Meadian OS time

    The time that half of enrolled patients died.

    Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy

Secondary Outcomes (6)

  • Cognitive function scores

    Measured at months 3, 6, 9, 12months after radiotherapy

  • Scores of quality of life

    Measured at months 3, 6, 9, 12months after radiotherapy

  • The time of neurological progression free survival

    Measured at months 3, 6, 9, 12months after radiotherapy

  • The time of intracranial overall progression free survival

    Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy

  • The time of overall progression free survival

    Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy

  • +1 more secondary outcomes

Study Arms (2)

SRS/SRT/Hypo-RT group

EXPERIMENTAL

The patients in this group will receive local treatment for BM.

Combination Product: Experimental group (SRS/SRT/Hypo-RT)

HA-WBRT group

ACTIVE COMPARATOR

The patients in this group will receive HA-WBRT.

Radiation: Controled group (HA-WBRT)

Interventions

Experimental group (SRS/SRT/Hypo-RT)COMBINATION_PRODUCT

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.

SRS/SRT/Hypo-RT group
Controled group (HA-WBRT)RADIATION

The prescription dose of HA-WBRT is 30Gy in 10 fraction.

HA-WBRT group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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;
  • 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;
  • 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.
  • 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);
  • \. 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).

You may not qualify if:

  • Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration;
  • Previous radiotherapy of the brain;
  • Patients can not tolerate immobilization or are with MRI contraindication (i.e., cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants);
  • Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases, increased intracranial pressure requiring immediate depression surgery.
  • 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);
  • Presence of other serious illnesses such as acute myocardial infarction, severe arrhythmia, or psychiatric disorders within the past 6 months;
  • 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;
  • Pregnant or lactating women;
  • Participation in another clinical study or observation period of competing trials, respectively;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nan Bi

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (3)

  • Yomo 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: 25005424BACKGROUND

  • Rusthoven 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: 32496550BACKGROUND

  • Robin 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: 29748022BACKGROUND

MeSH Terms

Conditions

Small Cell Lung CarcinomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Nan Bi, M.D

CONTACT

+86-10-87787692binan_email@163.com

Jianyang Wang, M.D

CONTACT

+86-10-87788876pkucell@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director of Thoracic Division, Department of Radiation Oncology

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 13, 2024

Study Start

September 1, 2023

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations

CN(1)