Clinical trial NCT05651802: PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small Cell Lung Cancer Limited Stage
Keywords: prophylactic cranial irradiation
brain MRI follow-up
prognosis
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2022-12-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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:

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 2-year brain metastasis-free survival estimated with kaplan-Meier method
timeFrame: Up to 2 years
Secondary outcomes:
measure: 2-year overall survival estimated with kaplan-Meier method
timeFrame: Up to 2 years
measure: Intra-cranial progressive patterns
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University, Cancer Center
state: Guangdong
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiao Hu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: