PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients

University of Chinese Academy Sciences

Status: Enrolling

Conditions: Small Cell Lung Cancer Limited Stage

Treatments: Radiation: Prophylactic cranial irradiation; Drug: Chemotherapy; Radiation: Thoracic radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05651802

PCI+MRI vs. MRI

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

220 participants in 2 patient groups

Control arm

Active Comparator group

Description:

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.

Treatment:

Drug: Chemotherapy

Radiation: Prophylactic cranial irradiation

Radiation: Thoracic radiotherapy

Study arm

Experimental group

Description:

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.

Treatment:

Drug: Chemotherapy

Radiation: Thoracic radiotherapy