PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients
NCT ID: NCT05651802
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2023-01-01
2026-06-30
Brief Summary
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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:
1. Whether the 2-year brain metastasis-free survival rate of the study group is not inferior to that of the control group.
2. The difference of 2-year overall survival rate between the control group and the study group.
3. 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control arm
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.
Prophylactic cranial irradiation
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 radiotherapy
Thoracic radiotherapy is a local treatment of tumors located in the chest using ionizing radiation.
Chemotherapy
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 arm
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.
Thoracic radiotherapy
Thoracic radiotherapy is a local treatment of tumors located in the chest using ionizing radiation.
Chemotherapy
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.
Interventions
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Prophylactic cranial irradiation
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 radiotherapy
Thoracic radiotherapy is a local treatment of tumors located in the chest using ionizing radiation.
Chemotherapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Zhejiang Cancer Hospital
OTHER
Responsible Party
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Hu Xiao
Principal Investigator
Principal Investigators
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Xiao Hu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Ming Chen, MD.PhD.
Role: primary
Xiao Hu, MD. PhD.
Role: primary
Other Identifiers
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PCI+MRI vs. MRI
Identifier Type: -
Identifier Source: org_study_id