Clinical trial · Observational
Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer
Real-world Study of Prophylactic Cranial Irradiation After Immunotherapy Combined With Chemotherapy for Extensive-stage Small Cell Lung Cancer
NCT04947774CI-TRIAL-00054032unknownClinicalTrials.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)
The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received chemotherapy and immunotherapy. This experimental study is a real-world research design to evaluate the effectiveness and safety of prophylactic cranial irradiation in patients with extensive-stage small cell lung cancer who with first-line chemotherapy combined with immunotherapy.
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 |
|---|---|---|---|
| Extensive-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic Cranial Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- prophylactic cranial irradiation group
- description
- The extensive-stage SCLC patients will receive prophylactic cranial irradiation after standard first-line chemotherapy combined with immunotherapy, until disease progression or death.
- interventionNames
- Radiation: Prophylactic Cranial Irradiation
- label
- Observation group
- description
- Patients with extensive-stage SCLC do not receive preventive craniocerebral irradiation after standard first-line chemotherapy combined with immunotherapy until the disease progresses or death.
Primary outcomes (1)
- measure
- Progression-free survival in the brain
- timeFrame
- 1 year
- description
- The length of time during and after treatment for a disease in which the patient lives with the disease but the intracranial lesions do not worsen
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Sign written informed consent; * With extensive small cell lung cancer; * Previously received first-line standard chemotherapy, with treatment response of CR or PR; * Can tolerate the radiotherapy process; * Be over 18 years old * Life expectancy ≥ 12 weeks; * With the Eastern Cancer Cooperative Group (ECOG) score 0-1 * After the systemic treatment was received, there was no brain metastasis on MR before brain preventive irradiation. Exclusion Criteria: * Exclude subjects with central nervous system (CNS) metastasis at the first diagnosis; * Pregnancy or breastfeeding; * Any other conclusive medical, psychiatric and/or social reasons determined by the researcher; * Subjects who have previously suffered from other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, stomach, colon, endometrial, cervical/dysplasia, melanoma or breast cancer) are not allowed to participate in the study. Unless he/she has been in complete remission at least 2 years before enrolling in the study, and does not need to receive other treatments or does not need to receive other treatments during the study; * Researchers believe that the treatment methods used in the study can cause harm or cause basic diseases whose toxicity is difficult to judge when judging adverse events.
References
Publications (16)
- BACKGROUNDTorre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. PMID 25651787
- BACKGROUNDChen W, Zheng R, Zhang S, Zeng H, Zuo T, Xia C, Yang Z, He J. Cancer incidence and mortality in China in 2013: an analysis based on urbanization level. Chin J Cancer Res. 2017 Feb;29(1):1-10. doi: 10.21147/j.issn.1000-9604.2017.01.01. PMID 28373748
- BACKGROUNDTakada M, Fukuoka M, Kawahara M, Sugiura T, Yokoyama A, Yokota S, Nishiwaki Y, Watanabe K, Noda K, Tamura T, Fukuda H, Saijo N. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with cisplatin and etoposide for limited-stage small-cell lung cancer: results of the Japan Clinical Oncology Group Study 9104. J Clin Oncol. 2002 Jul 15;20(14):3054-60. doi: 10.1200/JCO.2002.12.071. PMID 12118018
- BACKGROUNDHalthore A, Goenka A, Sharma R, Knisely JPS. Prophylactic Cranial Irradiation for Resectable Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):115-119. doi: 10.1016/j.cllc.2017.08.004. Epub 2017 Aug 26. PMID 28958889
- BACKGROUNDEdelman MJ. Prophylactic Cranial Irradiation for Small-Cell Lung Cancer: Time for a Reassessment. Am Soc Clin Oncol Educ Book. 2020 May;40:24-28. doi: 10.1200/EDBK_281041. PMID 32421453
- BACKGROUNDJanne PA, Freidlin B, Saxman S, Johnson DH, Livingston RB, Shepherd FA, Johnson BE. Twenty-five years of clinical research for patients with limited-stage small cell lung carcinoma in North America. Cancer. 2002 Oct 1;95(7):1528-38. doi: 10.1002/cncr.10841. PMID 12237922
- 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.