Clinical trial · Interventional
Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC
Twice-daily Radiotherapy by Simultaneous Integrated Boosting Technique Versus Twice-daily Standard Radiotherapy for Patients With Limited-stage Small Cell Lung Cancer: a Multicenter, Randomized, Controlled, Phase III Study
- 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 trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial. In order to establish whether the SIB technique can improve the results of twice-daily chemo-RT for patients with LS-SCLC, the investigators will primarily compare survival of patients treated with standard chemotherapy (cisplatin and etoposide) and either SIB twice-daily RT or standard dose twice-daily RT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiotherapy | — | UNRESOLVED | — |
| Small Cell Lung Cancer Limited Stage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIB | Radiation | — | UNRESOLVED |
| Standard | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SIB group
- description
- Patients in this group will receive concurrent twice-daily radiotherapy by SIB technique (95%PGTV 54Gy, 95%PTV 45Gy,both in 30 twice-daily fractions over 3 weeks, 5 days per week) and chemotherapy (etoposide and cisplatin).
- interventionNames
- Radiation: SIB
- type
- ACTIVE_COMPARATOR
- label
- BID group
- description
- Patients in this group will receive concurrent twice-daily standard radiotherapy (95%PTV 45Gy in 30 twice-daily fractions over 3 weeks, 5 days per week, without SIB) and chemotherapy (etoposide and cisplatin).
- interventionNames
- Radiation: Standard
Primary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Read the patient information and Sign the informed consent before enrollment * Either sex, age ≥18 and ≤70 * Histologically or cytologically confirmed SLCL * Limited stage disease(AJCC, 2009 version 7), stage I-III(T any, N any, M0) that can be safely treated with definitive radiation doses, excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, clinical nonmalignant diagnosis by investigator when the pleural is too few to obtain cytological evidence. * measurable lesion according RECIST 1.1 * PS ECOG 0-1 * having zero to two cycles of systemic chemotherapy with etoposide and cisplatin (cisplatin 60-80 mg/m2 at day1 or divided into two to three days, etoposide 100-120 mg/m2 at day 1 to 3, Q21d, and the treatment delay between two cycles shouldn't be more than 14days). * patients especially female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception. Man must also use adequate contraception * adequate haematological function: white blood cell ≥3.0×109/L , neutrophils ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥90g/L. * adequate liver and renal function: total bilirubin ≤1.5 ×upper limit normal , alanine transaminase and aspartate aminotransferase ≤1.5 ×upper limit normal, normal serum creatinine and/or calculated creatinine clearance ≥60ml/min. Exclusion Criteria: * prior surgical resection of the primary tumor or prior RT for lung cancer * mixed small-cell and non-small-cell histological features * contemporaneous immunotherapy or target therapy * pregnancy or lactation * physical or mental disease that could impact treatment plan * unable to understand the trial, or could not follow the process * to refuse the sign the informed consent. * no history of previous malignancy in the past 5 years (except non-melanomatous skin or in situ servix carcinoma) * be allergic to any known protocol in this trail * be enrolled in other clinical trial in past 30days
References
Publications (1)
- DERIVEDYu J, Jiang L, Zhao L, Yang X, Wang X, Yang D, Zhuo M, Chen H, Huang W, Zhu Z, Zhang M, Song Y, Li Q, Ma Z, Wang Q, Qu Y, Yu R, Yu H, Zhao J, Shi A; Trial Management Group. High-dose hyperfractionated simultaneous integrated boost radiotherapy versus standard-dose radiotherapy for limited-stage small-cell lung cancer in China: a multicentre, open-label, randomised, phase 3 trial. Lancet Respir Med. 2024 Oct;12(10):799-809. doi: 10.1016/S2213-2600(24)00189-9. Epub 2024 Aug 12. PMID 39146944