Clinical trial · Interventional
Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LS-SCLC
Phase III Randomized Study of Induction Chemotherapy Followed By Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Stage Small Cell Lung Cancer.
NCT02990780CI-TRIAL-00051502unknownPhase 3ClinicalTrials.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 protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of induction chemotherapy followed by accelerated hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for 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 |
|---|---|---|---|
| SCLC | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated hypofractionated concurrent chemo-radiotherapy | Radiation | — | UNRESOLVED |
| Conventionally fractionated concurrent chemo-radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventionally fractionated CRT
- description
- Induction chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.
- interventionNames
- Radiation: Conventionally fractionated concurrent chemo-radiotherapy
- type
- EXPERIMENTAL
- label
- Accelerated hypofractionated CRT
- description
- Induction chemotherapy followed by accelerated hypofractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.
- interventionNames
- Radiation: Accelerated hypofractionated concurrent chemo-radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed SCLC. * Male or female, aged 18-70 years. * ECOG performance status 0 to 2. * Limited-stage SCLC was defined as disease confined to one hemithorax and hilar,mediastinal, or supraclavicular nodes without pleural effusion, which can be safely encompassed within a tolerable radiation field. * No prior thoracic RT. * Weight loss in six months less than or equal to five percent. * FEV1 greater than 0.75L. * No severe internal diseases and no organ dysfunction. * No prior history of any tumor. * Skin test of CT contrast agents was negative. * Had received 1-6 cycles of VP16 plus DDP/carboplatin. * Voluntarily participated in this study and signed the informed consent form by himself or his agent. Had good compliance with the study procedures, and can cooperate with the relevant examination, treatment and follow-up. Exclusion Criteria: * Other tumor history(Except skin cancer/breast cancer/oral cancer/cervical cancer with expected lifespan more than or equal to 3 months). * Multiple primary lung cancer. * Any unstable systemic disease, including active infection, uncontrolled high blood pressure, unstable angina, newly observed angina pectoris within the past 3 months, congestive heart failure (New York heart association (NYHA) class II or higher), myocardial infarction onset six months before included into the group, and severe arrhythmia, liver, kidney, or metabolic disease in need of drug therapy. Human immunodeficiency virus (HIV) infection. * Women in pregnancy or lactation . * Patients with mental illness, considered as "can't fully understand the issues of this research". * Had received other chemotherapy regimens,any radiotherapy or TKI. * Refuse to write informed consent.
References
Publications (26)
- BACKGROUNDGovindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859. PMID 17008692
- BACKGROUNDBayman NA, Sheikh H, Kularatne B, Lorigan P, Blackhall F, Thatcher N, Faivre-Finn C. Radiotherapy for small-cell lung cancer-Where are we heading? Lung Cancer. 2009 Mar;63(3):307-14. doi: 10.1016/j.lungcan.2008.06.013. Epub 2008 Aug 3. PMID 18676057
- BACKGROUNDStinchcombe TE, Gore EM. Limited-stage small cell lung cancer: current chemoradiotherapy treatment paradigms. Oncologist. 2010;15(2):187-95. doi: 10.1634/theoncologist.2009-0298. Epub 2010 Feb 9. PMID 20145192
- BACKGROUNDMamdani H, Induru R, Jalal SI. Novel therapies in small cell lung cancer. Transl Lung Cancer Res. 2015 Oct;4(5):533-44. doi: 10.3978/j.issn.2218-6751.2015.07.20. PMID 26629422
- BACKGROUNDSemenova EA, Nagel R, Berns A. Origins, genetic landscape, and emerging therapies of small cell lung cancer. Genes Dev. 2015 Jul 15;29(14):1447-62. doi: 10.1101/gad.263145.115. PMID 26220992
- BACKGROUNDPietanza MC, Byers LA, Minna JD, Rudin CM. Small cell lung cancer: will recent progress lead to improved outcomes? Clin Cancer Res. 2015 May 15;21(10):2244-55. doi: 10.1158/1078-0432.CCR-14-2958. PMID 25979931
- BACKGROUNDKalemkerian GP. Advances in pharmacotherapy of small cell lung cancer. Expert Opin Pharmacother. 2014 Nov;15(16):2385-96. doi: 10.1517/14656566.2014.957180. Epub 2014 Sep 26. PMID 25255939
- Pignon JP, Arriagada R, Ihde DC, Johnson DH, Perry MC, Souhami RL, Brodin O, Joss RA, Kies MS, Lebeau B, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992 Dec 3;327(23):1618-24. doi: 10.1056/NEJM199212033272302.