Recruiting PHASE3 SCLC, Limited Stage

New treatment option for SCLC, Limited Stage

Official title Omitting CTV for Primary Tumor in LS-SCLC

ClinicalTrials.gov ID: NCT07008716

What this study is testing

What is Etoposide + carboplatin; Etoposide + cisplatin?

Etoposide + carboplatin; Etoposide + cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sclc, limited stage.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary...
  • Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;
  • Have measurable lesions per RECIST 1.1 criteria;
  • Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;
  • Lung function test: FEV1 ≥ 1 L (Optional);

You likely can't join if

  • Other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as...
  • Uncontrolled heart disease or myocardial infarction within the past 6 months;
  • Patients with a history of mental illness;
  • Pregnant and lactating patients;
  • Poorly controlled diabetes and hypertension;
  • Interstitial pneumonia or active pulmonary fibrosis;
See the full eligibility criteria
Who can join
  • 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 ≥ 80, ≤ 10% weight loss within the past 6 months;
  • Have measurable lesions per RECIST 1.1 criteria;
  • Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;
  • Lung function test: FEV1 ≥ 1 L (Optional);
  • Complete blood count: neutrophil count ≥ 1.5 x 10\^9/L, hemoglobin ≥ 100 g/L, platelet count ≥ 100 x 10\^9/L;
  • Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN);
  • Liver function: AST and ALT ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN;
  • Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent.
What rules you out
  • Other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary...
  • Uncontrolled heart disease or myocardial infarction within the past 6 months;
  • Patients with a 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).

The study team makes the final eligibility decision.

Where it's taking place

  • Guangzhou, Guangdong, China
  • Hangzhou, Zhejiang, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Guangzhou, Guangdong, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.