Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05651802

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

Led by Zhejiang Cancer Hospital · Updated on 2023-12-19

220

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

Z

Zhejiang Cancer Hospital

Lead Sponsor

S

Sun Yat-sen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of prophylactic cranial irradiation (PCI) compared to regular brain MRI follow-up alone in patients with limited-stage small cell lung cancer (SCLC) who have achieved complete remission after definitive thoracic radiotherapy and chemotherapy. The study aims to determine if MRI follow-up alone is not inferior to PCI in preventing brain metastases over two years, as well as differences in overall survival and quality of life between the two approaches. Participants are randomly assigned to one of two groups: the control group receives PCI plus regular brain MRI follow-up, while the study group undergoes regular brain MRI follow-up alone without PCI. The study focuses on patients who have finished their chest radiotherapy and chemotherapy and have shown a complete tumor response. Both interventions are monitored over a period of up to two years. During the study, participants will be regularly monitored with brain MRI scans to assess brain metastasis-free survival and overall survival rates. Researchers will also evaluate intracranial progression patterns and patients' overall quality of life. The study involves follow-up visits and clinical assessments over a two-year timeframe to gather these outcome measures and monitor participant health and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC)
  • Age 18 years or older
  • Karnofsky performance status (KPS) of 80 or higher
  • Limited-stage disease confined to one side of the chest including specified lymph nodes
  • Completed definitive chest radiotherapy and chemotherapy with complete tumor remission within 4-6 weeks
  • Good follow-up compliance
  • Voluntary informed consent provided
Not Eligible

You will not qualify if you...

  • History of malignant tumors within the past 5 years, except papillary thyroid cancer, non-malignant melanoma skin cancer, and cervical carcinoma in situ
  • Prior radical surgery except biopsy
  • History of psychiatric illness, pregnancy, or breastfeeding
  • Uncontrolled diabetes, hypertension, or severe active infections
  • Chronic central nervous system diseases
  • Contraindications to brain MRI examination
  • Other conditions deemed unsuitable by the doctor in charge

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 years

Participants who achieved complete remission after definitive radio-chemotherapy receive either prophylactic cranial irradiation (PCI) and regular brain MRI follow-up or regular brain MRI follow-up alone.

Regular brain MRI follow-up visits during treatment period

Trial Site Locations

Total: 2 locations

1

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

2

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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Research Team

X

Xiao Hu, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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