AzTrials
AzTrials

Limited Stage Small Cell Lung CancerPhase 3NCT04829708

Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy

A Phase 3 study testing MRI Surveillance and Prophylactic Cranial Irradiation in people with Limited Stage Small Cell Lung Cancer, run by Shandong Cancer Hospital and Institute at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, open,multicenter, randomized controlled phase III clinical trial. In patients with LS-SCLC who achieve remission after first-line chemoradiotherapy, the efficacy and safety of PCI or MRI surveillance is evaluated and analyzed. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Limited Stage Small Cell Lung Cancer
What is being tested?
MRI Surveillance and Prophylactic Cranial Irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
534 participants
Where
2 sitesChina
Study dates
26 Apr 2021to 15 Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological confirmation of LS-SCLC before first-line chemoradiotherapy (according to the staging system of the Veterans' Affairs Lung Study Group (VALSG), Appendix 2)；
  • Remission is achieved after first-line chemoradiotherapy (CR or PR determined by RECIST v1.1)；
  • Brain MRI examination should be performed to exclude metastatic lesions of brain parenchyma and meninges within four weeks before enrollment；
  • The ECOG PS score was 0~2；
  • The interval between the end of the last treatment cycle and the randomized grouping should be no more than 8 weeks；
  • Estimated survival time ≥ 12 weeks；
Show all 14Show fewer
  • Patients must agree to participate in the study, comply with the research plan and follow-up process. Written informed consent must obtained.
  • Male or female aged≥18 and≤75 years old;
  • For fertile women and man: Subjects are required to agree to maintain abstinence (no heterosexual intercourse) or use contraception with an annual failure rate of less than 1% during the study treatment period and within at least 6 months after the end of the study treatment period.
  • Hematological indexes: absolute neutrophil count≥1.5×109/ L, platelet count≥75×109 /L, haemoglobin≥9.0g/dL, serum albumin≥3g/dL；
  • Liver function: serum total bilirubin level≤1.5 times normal upper limit (ULN), glutamic pyruvic transaminase, glutamic oxaloacetic transaminase and alkaline phosphatase≤2.5 times ULN；
  • Renal function: defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 15ml/min (Cockcroft-Gault formula, Appendix 4); urinary protein negative or less than 2g in routine urine examination, or 24-hour urinary protein < 1g；
  • Good clotting function, defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5x ULN;. If the subject is receiving anticoagulant therapy, as long as PT is within the range of anticoagulant use；
  • Women of childbearing age must undergo a urinary pregnancy test within 7 days before the start of treatment and the results are negative and are not breastfeeding.

Who cannot join

  • Patients with extensive SCLC (Appendix 2)；
  • The subjects are confirmed to have brain or meningeal metastasis before they are randomly divided into groups；
  • During the 5 years before the start of the study, patients with malignant tumors other than SCLC, diseases with negligible risk of metastasis or death (such as expected 5-year OS > 90%) and malignant tumors expected to be cured (such as fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated by curable surgery, ductal carcinoma in situ treated by curable surgery)；
  • Previous head and neck radiation fields overlapped with PCI field；
  • MRI examination contraindicated
  • There is evidence that significantly uncontrolled concomitant disease may affect the compliance of the study program, including severe liver disease (such as liver cirrhosis), uncontrollable major seizures or superior vena cava syndrome；
Show all 21Show fewer
  • Major cardiovascular diseases, myocardial infarction or cerebrovascular events within 3 months before randomization, unstable arrhythmias, or unstable angina pectoris；
  • --Patients with known coronary artery disease, congestive heart failure that do not meet the above criteria, or left ventricular ejection fraction ((LVEF)) < 50% must receive a stable treatment plan and optimize it according to the advice of the attending physician, and consult a cardiologist if necessary。
  • Stroke (including hemorrhagic and ischemic) or transient ischemic attack occurred within 6 months before enrollment；
  • There were clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before entering the group, such as gastrointestinal bleeding, gastric ulcer bleeding, active hemoptysis or vasculitis；
  • Serious arteriovenous thrombosis events occurred within 3 months before enrollment, such as deep venous thrombosis, pulmonary embolism, etc. (except for implantable venous infusion port, catheter-derived thrombosis or superficial venous thrombosis, these conditions are not considered "severe" thromboembolism);
  • Diabetic ketoacidosis or hyperglycemia and hyperosmosis occurred in the past 6 months;
  • There was a history of hypertensive crisis and hypertensive encephalopathy;
  • Any other disease, metabolic disorder, abnormal result of physical examination or laboratory examination, and there is reason to suspect that it may affect the reliability of the results of the study or put the patient at high risk of treatment complications；
  • The results of HIV test is positive
  • --All patients must be tested for HIV; patients with positive results of HIV will be excluded.
  • Major surgery has been performed within 28 days before the start of the study treatment, or major surgery is expected to be performed during the study period (except those for diagnostic purposes)；
  • Severe infections occur at the beginning of the study, including, but not limited to, infectious complications requiring hospitalization, bacteremia, or severe pneumonia；
  • Pregnant or lactating women；
  • Previous history of severe neurological or mental disorders, including epilepsy, dementia or severe depression that interfere with assessment;
  • The researchers believe that some conditions of the patients may affect the evaluation of the efficacy of this study, as well as the compliance of patients with this study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jinming Yu, PhD contact

+8613806406293

sdyujinming@126.com

Xiangjiao Meng, PhD contact

+8613793150996

mengxiangjiao@126.com

China2 sites, 2 recruiting

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong, 250117

    Jinming Yu, PhD, 13806406293, sdyujinming@126.com

    Xiangjiao Meng, PhD, 13793150996, mengxiangjiao@126.com

    Recruiting

  • Shandong Cancer Hospital

    Jinan

    Xiangjiao Meng, PhD, 13793150996

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy: a Multicenter Randomized Controlled Phase III Clinical Trial

This is a prospective, open,multicenter, randomized controlled phase III clinical trial. In patients with LS-SCLC who achieve remission after first-line chemoradiotherapy, the efficacy and safety of PCI or MRI surveillance is evaluated and analyzed. PCI is performed in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. MRI surveillance alone (delaying radiation until the actual brain metastasis) may be not inferior to PCI.

Being tested
MRI Surveillance, Prophylactic Cranial Irradiation
Keywords
prophylactic cranial irradiation (PCI), MRI surveillance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI SurveillanceOther

    Also called Magnetic Resonance Imaging

    Receive MRI surveillance

  • Prophylactic Cranial IrradiationRadiation

    Also called PCI

    Receive PCI

Study groups in NCT04829708
Study groupRoleWhat they receive
PCI ArmActive comparatorPatients received PCI (recommended hippocampal protection) within 6 weeks after first-line treatment, with a total dose of 25 Gy, 2.5 Gy each time, once a day, 5 times a week, a total of 10 times. Brain enhancement MRI examination is performed every 3 months in first two years, and then performed every 6 months until the brain metastasis occur.
Receives: Other: MRI Surveillance; Radiation: Prophylactic Cranial Irradiation
MRI ArmExperimentalPatients undergo enhancement MRI examination every 3 months in first two years, and then performed every 6 months until the brain metastasis occur. Once brain metastases occur, brain radiotherapy and systemic treatment should be conducted with the follow-up observation of brain enhancement MRI continuing.
Receives: Other: MRI Surveillance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    To compare the efficacy of PCI and MRI surveillance in patients with LS-SCLC.

    Measured: From date of randomization until the date of death due to any cause, assessed up to 2 years.

Secondary outcomes (5)

  1. 1-year overall survival rate (1y-OS%)

    Rate of patients surviving at 1 year.

    Measured: 1-year

  2. 3-year overall survival rate (3y-OS%)

    Rate of patients surviving at 3 year.

    Measured: 3-year

  3. Progression-free survival (PFS)

    Measured: From the date of randomization until the date of the first onset of disease progression or the time to die of any cause, whichever occurs first, assessed up to 2 years.

  4. Brain metastasis rate

    To compare brain metastasis rate between the two arms.

    Measured: From the date of randomization until the date of occurrence of brain metastasis, assessed up to 2 years.

  5. Cumulative incidence of neurocognitive impairment

    To compare the neurocognitive toxicities of PCI and MRI surveillance in patients with LS-SCLC.

    Measured: From the date of randomization until the date of occurrence of neurocognitive impairment , assessed up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2021
  2. Study start26 Apr 2021 (estimated)
  3. Primary completion15 Apr 2026 (estimated)
  4. Study completion15 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
534 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04829708
Sponsor's protocol ID
LS-SCLC-III-PCI 2021
Status last verified
Apr 2021
First submitted
27 Mar 2021
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wei Z, Chen Y, Yu J, Meng X. Prophylactic cranial irradiation versus active MRI surveillance for limited-stage small-cell lung cancer achieving response after chemoradiotherapy: a protocol for a randomized, controlled, multicenter, phase III trial. Respir Res. 2026 Sep 8;27(1):362. doi: 10.1186/s12931-026-03902-0.

    PubMed 42763407

  • Schneiders FL, Senan S. New strategies for patients with limited-stage small-cell lung cancer. Lancet Respir Med. 2024 Oct;12(10):748-750. doi: 10.1016/S2213-2600(24)00223-6. Epub 2024 Aug 12. No abstract available.

    PubMed 39146945

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MRI Surveillance and Prophylactic Cranial Irradiation in people with Limited Stage Small Cell Lung Cancer, run by Shandong Cancer Hospital and Institute at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jinming Yu, PhD (+8613806406293, sdyujinming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: From date of randomization until the date of death due to any cause, assessed up to 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04829708, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in