Clinical trial · Interventional
SBRT Compared With IMRT Concurrently With Chemotherapy in Treating Patients With LS-SCLC
Stereotactic Body Radiation Therapy Compared With Intensity Modulated Radiation Therapy Concurrently With Chemotherapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
NCT02738723CI-TRIAL-00021751unknownPhase 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)
As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present, the aim of this study is to evaluate the efficacy and safety of stereotactic body radiation therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell lung cancer
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 |
|---|---|---|---|
| EP | Drug | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GROUP 1
- description
- SBRT plus EP
- interventionNames
- Radiation: SBRT
- Drug: EP
- type
- ACTIVE_COMPARATOR
- label
- GROUP 2
- description
- IMRT plus EP
- interventionNames
- Radiation: IMRT
- Drug: EP
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of SCLC * limited-stage disease is defined as disease confined to the ipsilateral hemithorax, which can be safely encompassed within a radiation field * No prior chemotherapy, or radiotherapy * Performance status of 0, 1, 2 on the ECOG criteria. * At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000). * Adequate hematologic (neutrophil count \>= 1,500/uL, platelets \>= 100,000/uL), hepatic (transaminase =\< upper normal limit(UNL)x2.5, bilirubin level =\< UNLx1.5), and renal (creatinine =\< UNL) function * If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment. Exclusion Criteria: * Non small cell lung cancer and carcinoid * Supraclavicular lymphadenopathy * Inability to comply with protocol or study procedures. * Moderate and severe ventilation dysfunction * Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease * Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. * Pregnant or breast-feeding. * Enrollment in other study within 30 days
References
Publications (2)
- BACKGROUNDLi C, Xiong Y, Zhou Z, Peng Y, Huang H, Xu M, Kang H, Peng B, Wang D, Yang X. Stereotactic body radiotherapy with concurrent chemotherapy extends survival of patients with limited stage small cell lung cancer: a single-center prospective phase II study. Med Oncol. 2014 Dec;31(12):369. doi: 10.1007/s12032-014-0369-x. Epub 2014 Nov 22. PMID 25416052
- 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