Small Cell Lung Cancer Limited StageNCT05651802
PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients
A study testing Prophylactic cranial irradiation, Thoracic radiotherapy and Chemotherapy in people with Small Cell Lung Cancer Limited Stage, run by Zhejiang Cancer Hospital at 2 sites in China.
Trial summary
At present, prophylactic cranial irradiation (PCI) is part of standard care for patients with limited-stage small cell lung cancer (SCLC) who have achieved good response after definitive thoracic radiotherapy and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer Limited Stage
- What is being tested?
- Prophylactic cranial irradiation, Thoracic radiotherapy and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically proven diagnosis of SCLC.
- Age ≥ 18 years.
- Karnofsky performance status ( KPS) ≥80.
- The limited-stage is defined as the tumor confined to one side of the chest, including ipsilateral hilar, bilateral mediastinum, and bilateral supraclavicular lymph nodes. (The definition of metastatic lymph nodes is that the short diameter ≥ 1cm or PET-CT shows increased metabolism with SUV≥2.5, or proved by mediastinoscopy/EBUS/TBNA biopsy. The thickness of pleural effusion on chest CT is less than 1cm (unless cytology proves to be malignant pleural effusion). According to 8th AJCC/UICC TNM staging system, it is the I-IIIC without intrapulmonary metastasis.
- Patients who have received definitive chest radiotherapy and chemotherapy and achieved complete remission of tumor within 4-6 weeks after the end of radio-chemotherapy (in accordance with the Response Evaluation Criteria in Solid Tumors v.1.1 including enhanced CT scan of chest and abdomen, enhanced brain MRI, bone scan and tumor markers).
- Good follow-up compliance;
- Fully understand this study, and voluntarily sign the informed consent form.
Who cannot join
- Patients with a history of malignant tumors (past or concurrent) within 5 years, excluding papillary thyroid cancer, non-malignant melanoma skin cancer and cervical carcinoma in situ.
- Patients who have received radical surgery (excluding biopsy).
- Patients with psychiatric history, pregnancy and lactation.
- Uncontrolled diabetes, hypertension, severe active infection.
- Patients with chronic diseases of central nervous system.
- Patients with contraindications of brain MRI examination.
- Other situations deemed unsuitable by the doctor in charge.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, 510060
Ming Chen, MD.PhD.
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiao Hu, MD. PhD., +86-571-88128172, huxiao@zjcc.org.cn
About this study
Official title: Prophylactic Cranial Irradiation and Brain MRI Follow-up Versus Brain MRI Follow-up Alone in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Complete Remission After Definitive Radio-chemotherapy: a Prospective Randomized Trial
At present, prophylactic cranial irradiation (PCI) is part of standard care for patients with limited-stage small cell lung cancer (SCLC) who have achieved good response after definitive thoracic radiotherapy and chemotherapy. However, the value of PCI is being challenged in the era when MRI examination of brain has been popularized.
The goal of this clinical study is to compare PCI and regular brain MRI follow-up (control arm) and regular brain MRI follow-up alone (study arm) in patients with limited-stage SCLC who have received definitive radiotherapy and chemotherapy and acheived complete remission (CR) of tumor.
Read more
The main questions to answer are:
- Whether the 2-year brain metastasis-free survival rate of the study group is not inferior to that of the control group.
- The difference of 2-year overall survival rate between the control group and the study group.
- Whether the patients in the study group have better overall quality of life than those in the control group.
Participants will randomly receive either PCI and regular brain MRI follow-up or regular brain MRI follow-up alone.
- Conditions
- Small Cell Lung Cancer Limited Stage
- Being tested
- Prophylactic cranial irradiation, Thoracic radiotherapy, Chemotherapy
- Keywords
- prophylactic cranial irradiation, brain MRI follow-up, prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic cranial irradiationRadiation
Prophylactic cranial irradiation (PCI) is actually a habitual statement. It is a technique used to eliminate tiny metastatic lesions that have already existed in the brain, but can not be found by brain MRI and other inspection methods.
Thoracic radiotherapyRadiation
Thoracic radiotherapy is a local treatment of tumors located in the chest using ionizing radiation.
ChemotherapyDrug
Chemotherapy is the abbreviation of chemical drug therapy. It is a treatment method that uses chemical drugs to prevent the proliferation, invasion and metastasis of cancer cells, and finally kill cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Patients who are randomized to control arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive PCI and regular brain MRI follow-up. Receives: Radiation: Prophylactic cranial irradiation; Radiation: Thoracic radiotherapy; Drug: Chemotherapy |
| Study arm | Experimental | Patients who are randomized to study arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive regular brain MRI follow-up alone. Receives: Radiation: Thoracic radiotherapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year brain metastasis-free survival estimated with kaplan-Meier method
To test with a one-sided significance of 5% whether for the treatment of limited-stage SCLC patients, brain MRI follow-up alone is non-inferior in terms of 2-year brain metastasis-free survival compared to PCI and brain MRI follow-up. Participants were monitored for up to 2 years. The brain metastasis-free survival time is defined as the time between the date of the first treatment until the date of first documented diagnosis of brain metastasis or the date of death from any cause.
Measured: Up to 2 years
Secondary outcomes (2)
2-year overall survival estimated with kaplan-Meier method
To compare 2-year overall survival between patients who receive brain MRI follow-up alone and those who receive both PCI and brain MRI follow-up, with kaplan-Meier estimates. Participants were monitored for up to 2 years. The overall survival time is defined as the time between the date of the first treatment until the date of death from any cause.
Measured: Up to 2 years
Intra-cranial progressive patterns
To compare the intra-cranial progressive patterns between patients who receive brain MRI follow-up alone and those who receive both PCI and brain MRI follow-up within 2 years. Intra-cranial progression is evaluated via the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In this study, Intra-cranial progressive disease is defined as the new lesions developed in the brain.
Measured: 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.
- First posted15 Dec 2022
- Study start1 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung Cancer Limited StageStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Xiao, Zhejiang Cancer Hospital
- Investigators
- Xiao Hu, MD, PhD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651802
- Sponsor's protocol ID
- PCI+MRI vs. MRI
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee HI, Noh JM, Lee TH, Choi EK, Kim SS, Shin YS, Ahn YC, Pyo H, Yang K, Yang E, Wu HG, Lee JH, Kim BH, Koh M, Song SY, Kim HJ. Refining Patient Selection for Prophylactic Cranial Irradiation in Limited-Stage SCLC: A Multicenter Cohort Study. J Natl Compr Canc Netw. 2025 Aug 6;23(9):371-378. doi: 10.6004/jnccn.2025.7034.
PubMed 40769176
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Cranial Irradiation and Brain MRI Follow-up Versus Brain MRI Follow-up Alone in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Complete Remission After Definitive Radio-chemotherapy: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05651802
- Acronym / sponsor ID
- PCI+MRI vs. MRI
- Conditions
- Small Cell Lung Cancer Limited Stage
- Keywords
- prophylactic cranial irradiation, brain MRI follow-up, prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present, prophylactic cranial irradiation (PCI) is part of standard care for patients with limited-stage small cell lung cancer (SCLC) who have achieved good response after definitive thoracic radiotherapy and chemotherapy. However, the value of PCI is being challenged in the era when MRI examination of brain has been popularized.
The goal of this clinical study is to compare PCI and regular brain MRI follow-up (control arm) and regular brain MRI follow-up alone (study arm) in patients with limited-stage SCLC who have received definitive radiotherapy and chemotherapy and acheived complete remission (CR) of tumor.
The main questions to answer are:
- Whether the 2-year brain metastasis-free survival rate of the study group is not inferior to that of the control group.
- The difference of 2-year overall survival rate between the control group and the study group.
- Whether the patients in the study group have better overall quality of life than those in the control group.
Participants will randomly receive either PCI and regular brain MRI follow-up or regular brain MRI follow-up alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Radiation: Prophylactic cranial irradiation, Radiation: Thoracic radiotherapy, Drug: ChemotherapyPatients who are randomized to control arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive PCI and regular brain MRI follow-up. |
| Study arm | Experimental | Radiation: Thoracic radiotherapy, Drug: ChemotherapyPatients who are randomized to study arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive regular brain MRI follow-up alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically/cytologically proven diagnosis of SCLC.
- Age ≥ 18 years.
- Karnofsky performance status ( KPS) ≥80.
- The limited-stage is defined as the tumor confined to one side of the chest, including ipsilateral hilar, bilateral mediastinum, and bilateral supraclavicular lymph nodes. (The definition of metastatic lymph nodes is that the short diameter ≥ 1cm or PET-CT shows increased metabolism with SUV≥2.5, or proved by mediastinoscopy/EBUS/TBNA biopsy. The thickness of pleural effusion on chest CT is less than 1cm (unless cytology proves to be malignant pleural effusion). According to 8th AJCC/UICC TNM staging system, it is the I-IIIC without intrapulmonary metastasis.
- Patients who have received definitive chest radiotherapy and chemotherapy and achieved complete remission of tumor within 4-6 weeks after the end of radio-chemotherapy (in accordance with the Response Evaluation Criteria in Solid Tumors v.1.1 including enhanced CT scan of chest and abdomen, enhanced brain MRI, bone scan and tumor markers).
Key exclusion criteria (7 listed)
- Patients with a history of malignant tumors (past or concurrent) within 5 years, excluding papillary thyroid cancer, non-malignant melanoma skin cancer and cervical carcinoma in situ.
- Patients who have received radical surgery (excluding biopsy).
- Patients with psychiatric history, pregnancy and lactation.
- Uncontrolled diabetes, hypertension, severe active infection.
- Patients with chronic diseases of central nervous system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic cranial irradiationProphylactic cranial irradiation (PCI) is actually a habitual statement. It is a technique used to eliminate tiny metastatic lesions that have already existed in the brain, but can not be found by brain MRI and other inspection methods. | Radiation | Control arm |
| Thoracic radiotherapyThoracic radiotherapy is a local treatment of tumors located in the chest using ionizing radiation. | Radiation | Control arm, Study arm |
| ChemotherapyChemotherapy is the abbreviation of chemical drug therapy. It is a treatment method that uses chemical drugs to prevent the proliferation, invasion and metastasis of cancer cells, and finally kill cancer cells. | Drug | Control arm, Study arm |
Primary outcome
2-year brain metastasis-free survival estimated with kaplan-Meier method
Time frame: Up to 2 years
To test with a one-sided significance of 5% whether for the treatment of limited-stage SCLC patients, brain MRI follow-up alone is non-inferior in terms of 2-year brain metastasis-free survival compared to PCI and brain MRI follow-up. Participants were monitored for up to 2 years. The brain metastasis-free survival time is defined as the time between the date of the first treatment until the date of first documented diagnosis of brain metastasis or the date of death from any cause.
2 secondary outcomes
2-year overall survival estimated with kaplan-Meier method
Time frame: Up to 2 years
Intra-cranial progressive patterns
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Derived from this study: PubMed 40769176Lee HI, Noh JM, Lee TH, Choi EK, Kim SS, Shin YS, Ahn YC, Pyo H, Yang K, Yang E, Wu HG, Lee JH, Kim BH, Koh M, Song SY, Kim HJ. Refining Patient Selection for Prophylactic Cranial Irradiation in Limited-Stage SCLC: A Multicenter Cohort Study. J Natl Compr Canc Netw. 2025 Aug 6;23(9):371-378. doi: 10.6004/jnccn.2025.7034.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao Hu, MD, PhD principal investigator
Zhejiang Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic cranial irradiation, Thoracic radiotherapy and Chemotherapy in people with Small Cell Lung Cancer Limited Stage, run by Zhejiang Cancer Hospital 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Hu, MD, PhD (+86-571-88128172, huxiao@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year brain metastasis-free survival estimated with kaplan-Meier method (time frame: 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 NCT05651802, which also lists 1 linked publication.
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 19 Dec 2023.