Clinical trial · Interventional
Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer
Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy Compared With Twice-daily Radiotherapy in Limited Small-cell Lung Cancer Treated Concurrently With Cisplatin and Etoposide
NCT02337712CI-TRIAL-00049680unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 Phase II randomized study is to determine whether once-daily simultaneous modulated accelerated thoracic radiotherapy (RT) resulted in better survival than twice-daily RT for patients with limited-stage small-cell lung cancer (LD-SCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| b.i.d.RT | Radiation | — | UNRESOLVED |
| etoposide and cisplatin | Drug | — | UNRESOLVED |
| q.d. RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- q.d. RT
- description
- q.d. RT (65 Gy in 26 fractions) to the chest and concurrent etoposide and cisplatin
- interventionNames
- Radiation: q.d. RT
- Drug: etoposide and cisplatin
- type
- ACTIVE_COMPARATOR
- label
- b.i.d.RT
- description
- b.i.d.RT (45Gy in 30 fractions) to the chest and concurrent etoposide and cisplatin
- interventionNames
- Radiation: b.i.d.RT
- Drug: etoposide and cisplatin
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic confirmation of SCLC. Imaging studies' confirmation of limited stage. * No previous chest radiotherapy, chemotherapy or biotherapy. * Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * White blood cell count ≥4×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L; serum creatinine and total bilirubin 1.5 times or less the upper limits of normal (ULN), aspartate aminotransferase two times or less the ULN. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Weight loss ≤10% within the past 3 months. * Forced expiratory volume in 1 s \>1 L. Exclusion Criteria: * Previous or recent another malignancy. * A myocardial infarction within 6 months or had uncontrolled congestive heart failure, uncontrolled arrhythmia. * Malignant pleural or pericardial effusion. * Pregnant or Lactating. * Weight loss \>10% within the past 3 months. * Drug addiction, long-term alcohol abuse and AIDS patients.
References
Publications (17)
- BACKGROUNDKong FM, Lally BE, Chang JY, Chetty IJ, Decker RH, Ginsburg ME, Kestin LL, Langer CJ, Movsas B, Videtic GM, Willers H, Rosenzweig KE; Expert Panel on Radiation Oncology-Lung. ACR Appropriateness Criteria(R) radiation therapy for small-cell lung cancer. Am J Clin Oncol. 2013 Apr;36(2):206-13. doi: 10.1097/COC.0b013e31827e5523. PMID 23511336
- BACKGROUNDSocinski MA, Bogart JA. Limited-stage small-cell lung cancer: the current status of combined-modality therapy. J Clin Oncol. 2007 Sep 10;25(26):4137-45. doi: 10.1200/JCO.2007.11.5303. PMID 17827464
- BACKGROUNDTurrisi AT 3rd, Kim K, Blum R, Sause WT, Livingston RB, Komaki R, Wagner H, Aisner S, Johnson DH. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28;340(4):265-71. doi: 10.1056/NEJM199901283400403. PMID 9920950
- BACKGROUNDChen GY, Jiang GL, Wang LJ, Qian H, Fu XL, Yang H, Wu KL, Zhao S. Cisplatin/etoposide chemotherapy combined with twice daily thoracic radiotherapy for limited small-cell lung cancer: a clinical phase II trial. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):70-5. doi: 10.1016/j.ijrobp.2004.04.058. PMID 15629596
- BACKGROUNDHu X, Bao Y, Zhang L, Guo Y, Chen YY, Li KX, Wang WH, Liu Y, He H, Chen M. Omitting elective nodal irradiation and irradiating postinduction versus preinduction chemotherapy tumor extent for limited-stage small cell lung cancer: interim analysis of a prospective randomized noninferiority trial. Cancer. 2012 Jan 1;118(1):278-87. doi: 10.1002/cncr.26119. Epub 2011 May 19. PMID 21598237
- BACKGROUNDChoi NC, Herndon JE 2nd, Rosenman J, Carey RW, Chung CT, Bernard S, Leone L, Seagren S, Green M. Phase I study to determine the maximum-tolerated dose of radiation in standard daily and hyperfractionated-accelerated twice-daily radiation schedules with concurrent chemotherapy for limited-stage small-cell lung cancer. J Clin Oncol. 1998 Nov;16(11):3528-36. doi: 10.1200/JCO.1998.16.11.3528.