Clinical trial · Interventional
Hypofraction Radiotherapy for Limited-Stage Small Cell Lung Cancer
Hypofraction Radiotherapy for Limited-Stage Small Cell Lung Cancer: A Pilot 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)
Concurrent chemoradiotherapy is the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study. In 2021, a phase II trial demonstrated that 60Gy/40f twice daily was superior to the standard 45Gy/30f twice daily in light of overall survival (2y OS 74.2% vs. 39% p=0.0005), which to some extent implied that higher dose may confer better survival. Hypofractionated radiotherapy was another useful modality to increase biological effective dose with the advantage of short course and convenience. The effectiveness and safety of 60Gy/15f has been demonstrated in the treatment of locally advanced non-small cell lung cancer. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy for stage III locally advanced small cell lung cancer.
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 |
|---|---|---|---|
| Efficacy, Self | — | UNRESOLVED | — |
| Safety Issues | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-dose hypofraction Arm | Radiation | — | UNRESOLVED |
| Low-dose hypofraction Arm (Standard BED) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-dose hypofraction Arm
- description
- Patients in this arm (High-dose hypofraction Arm) would receive high-dose fractionated radiotherapy with 60Gy/15f.
- interventionNames
- Radiation: High-dose hypofraction Arm
- type
- EXPERIMENTAL
- label
- Low-dose hypofraction Arm (Standard BED)
- description
- Patients in this arm (Low-dose hypofraction Arm) would receive high-dose fractionated radiotherapy with 48Gy/12f.
- interventionNames
- Radiation: Low-dose hypofraction Arm (Standard BED)
Primary outcomes (3)
- measure
- Rate of radiation-induced pneumonitis (CTCAE V4.0)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18-75 years old; * ECOG 0-1; * Small cell lung cancer; * Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonagraph, bone scan or cranial MRI and PET-CT; * Signature of inform consent. Exclusion Criteria: * Younger than 18 years old or older than 75 years old; * ECOG\>1; * Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma; * Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonagraph, bone scan or cranial MRI and PET-CT; * No signature of inform consent.
References
Publications (1)
- DERIVEDLi XY, Yan B, Zhang JQ, Li Y, Xia DQ, Xie W, He Y, Wang JG, Ma J, Cao LJ, Qian D. Short-course hypofractionated radiotherapy of 4 Gy per fraction for limited-stage small cell lung cancer: a randomized pilot trial. Transl Lung Cancer Res. 2025 Aug 31;14(8):2996-3008. doi: 10.21037/tlcr-2025-281. Epub 2025 Aug 26. PMID 40948832