Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07008716

Omitting CTV for Primary Tumor in LS-SCLC

Led by Sun Yat-sen University · Updated on 2025-06-06

852

Participants Needed

2

Research Sites

395 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (LS-SCLC). Patients in the experimental group would receive radiotherapy with omission of the clinical target volume (CTV) for the primary tumor, while those in the control group would receive radiotherapy including CTV. The efficacy and toxicity of the two groups are compared to provide evidence for the radiotherapy of LS-SCLC. The target volume of LS-SCLC may be reduced by omitting CTV without increasing local recurrence but potentially reducing the dose to organs at risk and the side effects.

CONDITIONS

Official Title

Omitting CTV for Primary Tumor in LS-SCLC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis
  • Aged 18-75 years, KPS score 64 80, 64 10% weight loss within the past 6 months
  • Measurable lesions per RECIST 1.1 criteria
  • No disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin
  • Lung function test: FEV1 64 1 L (optional)
  • Complete blood count: neutrophil count 64 1.5 x 10^9/L, hemoglobin 64 100 g/L, platelet count 64 100 x 10^9/L
  • Renal function: serum creatinine 64 1.5 x upper limit of normal (ULN)
  • Liver function: AST and ALT 64 2.5 x ULN, bilirubin 64 1.5 x ULN
  • Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent
Not Eligible

You will not qualify if you...

  • Other malignant tumors (prior or concurrent), except those curatively treated with disease-free survival 64 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer
  • Uncontrolled heart disease or myocardial infarction within the past 6 months
  • History of mental illness
  • Pregnant and lactating patients
  • Poorly controlled diabetes and hypertension
  • Interstitial pneumonia or active pulmonary fibrosis
  • Active infection
  • Other conditions unsuitable for enrollment (per investigator judgment)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

2

Zhejiang Provincial Cancer Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

Loading map...

Research Team

M

Ming Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here