Clinical trial · Interventional
Omitting CTV for Primary Tumor in LS-SCLC
Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Progression | — | UNRESOLVED | — |
| Radiation Exposure | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
| SCLC, Limited Stage | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Creating CTV for primary tumor | Radiation | — | UNRESOLVED |
| Etoposide + carboplatin; Etoposide + cisplatin | Drug | — | UNRESOLVED |
| prophylactic cranial irradiation (PCI) | Radiation | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Creating CTV for primary tumor.
- interventionNames
- Radiation: Radiation Therapy
- Drug: Etoposide + carboplatin; Etoposide + cisplatin
- Radiation: Creating CTV for primary tumor
- Radiation: prophylactic cranial irradiation (PCI)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Omitting CTV for primary tumor.
- interventionNames
- Radiation: Radiation Therapy
- Drug: Etoposide + carboplatin; Etoposide + cisplatin
- Radiation: prophylactic cranial irradiation (PCI)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis; 2. Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months; 3. Have measurable lesions per RECIST 1.1 criteria; 4. Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin; 5. Lung function test: FEV1 ≥ 1 L (Optional); 6. Complete blood count: neutrophil count ≥ 1.5 x 10\^9/L, hemoglobin ≥ 100 g/L, platelet count ≥ 100 x 10\^9/L; 7. Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN); 8. Liver function: AST and ALT ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN; 9. Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent. Exclusion Criteria: 1. 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; 2. Uncontrolled heart disease or myocardial infarction within the past 6 months; 3. Patients with a history of mental illness; 4. Pregnant and lactating patients; 5. Poorly controlled diabetes and hypertension; 6. Interstitial pneumonia or active pulmonary fibrosis; 7. Active infection; 8. Other conditions unsuitable for enrollment (per investigator judgment).
References
Publications (0)
Data not yet available