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Recruiting NCT07008716

Omitting CTV for Primary Tumor in LS-SCLC

Phase III Interventional SCLC, Limited Stage Radiation Exposure Radiotherapy Side Effect Progression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation Therapy, Etoposide + carboplatin; Etoposide + cisplatin, Creating CTV for primary tumor, prophylactic cranial irradiation (PCI).
Who it may be relevant to
Registry conditions: SCLC, Limited Stage, Radiation Exposure, Radiotherapy Side Effect, Progression. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial

Overview

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.

Interventions

  • Radiation Radiation Therapy
    Twice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy
  • Drug Etoposide + carboplatin; Etoposide + cisplatin
    Carboplatin IV (AUC=5) on day 1 combined with etoposide IV (100mg/m2) on days 1-3, or cisplatin IV (25mg/m2) on days 1-3 combined with etoposide IV (100mg/m2) on days 1-3. Treatment is repeated every 21 days for 4-6 cycles.
  • Radiation Creating CTV for primary tumor
    A margin of 0.8 cm beyond the gross target volume of primary tumor.
  • Radiation prophylactic cranial irradiation (PCI)
    Beginning 4-6 weeks after chemoradiotherapy completion, patients in both arms who achieve a complete or partial response without brain metastasis receive PCI at 25 Gy/10 fractions or 26 Gy/13 fractions, delivered once daily (5 days per week).

Primary outcome measures

  • Local progression free survival [Time frame: From the date chemotherapy commenced to the first clinical or radiological evidence of progressive disease at the primary site or death, whichever occurs first, to be assessed up to 3 years]
  • Severe toxicity free survival [Time frame: From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years]
Secondary outcome measures (4)
  • Overall survival [Time frame: From the date chemotherapy commenced to the date of death from any cause or the end of follow-up at 3 years]
  • Progression free survival [Time frame: From the date chemotherapy commenced to disease progression or death, whichever occurs first, to be assessed up to 3 years]
  • Number of participants with recurrence or metastasis as evaluated by RECIST 1.1 [Time frame: From the date chemotherapy commenced to the end of follow-up at 3 years]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: From the date chemotherapy commenced to the end of follow-up at 3 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 thyroid cancer;
  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Sun Yat-sen University Cancer Center — Guangzhou
  • Zhejiang Provincial Cancer Hospital — Hangzhou

Identifiers

NCT: NCT07008716 · B2022-792

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗