Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer

Extensive-stage Small-cell Lung Cancer Clinical Trial

Official title:

Real-world Study of Prophylactic Cranial Irradiation After Immunotherapy Combined With Chemotherapy for Extensive-stage Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04947774
• Other study ID #: NCC2622
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: October 2022

Study information

• Verified date: September 2021
• Source: Chinese Academy of Medical Sciences
• Contact: Liu Wen-Yang, MD
• Phone: 8613810753633
• Email: liuwenyang26[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This study is a prospective trial. This study included ES-SCLC patients who response after standard first-line treatment, and aimed to explore the safety and effectiveness of prophylactic cranial irradiation in this treatment modality.

The primary endpoint is progression-free survival in the brain.The secondary endpoints includes OS, PFS. The indicators for evaluating safety are the incidence and severity of adverse events.The exploratory endpoint is the molecular biomarkers for efficacy and toxicity predicting from tumor tissue and peripheral blood TMB.

The trial was designed by the National Cancer Center/Cancer Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College. The hypothesis is that preventive brain irradiation is safe and effective in the treatment of extensive SCLC combined with chemotherapy and immunotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extensive-stage Small-cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Radiation:
• Prophylactic Cranial Irradiation
The extensive-stage SCLC patients will receive prophylactic cranial irradiation ±immunotherapy after standard first-line chemotherapy combined with immunotherapy, until disease progression or death

Locations

Country	Name	City	State
China	Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (16)

Chen 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. — View Citation

Edelman 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. Review. — View Citation

Ge W, Xu H, Yan Y, Cao D. The effects of prophylactic cranial irradiation versus control on survival of patients with extensive-stage small-cell lung cancer: a meta-analysis of 14 trials. Radiat Oncol. 2018 Aug 23;13(1):155. doi: 10.1186/s13014-018-1101-3. — View Citation

Govindan 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. — View Citation

Halthore 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. Review. — View Citation

Jänne 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. — View Citation

Lara PN Jr, Natale R, Crowley J, Lenz HJ, Redman MW, Carleton JE, Jett J, Langer CJ, Kuebler JP, Dakhil SR, Chansky K, Gandara DR. Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124. J Clin Oncol. 2009 May 20;27(15):2530-5. doi: 10.1200/JCO.2008.20.1061. Epub 2009 Apr 6. — View Citation

Nosaki K, Seto T, Shimokawa M, Takahashi T, Yamamoto N. Is prophylactic cranial irradiation (PCI) needed in patients with extensive-stage small cell lung cancer showing complete response to first-line chemotherapy? Radiother Oncol. 2018 Jun;127(3):344-348. doi: 10.1016/j.radonc.2018.04.010. Epub 2018 May 7. Review. — View Citation

Pezzi TA, Fang P, Gjyshi O, Feng L, Liu S, Komaki R, Lin SH. Rates of Overall Survival and Intracranial Control in the Magnetic Resonance Imaging Era for Patients With Limited-Stage Small Cell Lung Cancer With and Without Prophylactic Cranial Irradiation. JAMA Netw Open. 2020 Apr 1;3(4):e201929. doi: 10.1001/jamanetworkopen.2020.1929. — View Citation

Rimner A, Wu AJ, Grills IS. What Is the Impact of Hippocampus Avoidance-Prophylactic Cranial Irradiation on Neurocognitive Preservation? J Thorac Oncol. 2021 May;16(5):722-724. doi: 10.1016/j.jtho.2021.02.026. — View Citation

Socinski MA, Smit EF, Lorigan P, Konduri K, Reck M, Szczesna A, Blakely J, Serwatowski P, Karaseva NA, Ciuleanu T, Jassem J, Dediu M, Hong S, Visseren-Grul C, Hanauske AR, Obasaju CK, Guba SC, Thatcher N. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92. doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31. — View Citation

Spigel DR, Hainsworth JD, Shipley DL, Mekhail TM, Zubkus JD, Waterhouse DM, Daniel DB, Burris HA 3rd, Greco FA. Amrubicin and carboplatin with pegfilgrastim in patients with extensive stage small cell lung cancer: A phase II trial of the Sarah Cannon Oncology Research Consortium. Lung Cancer. 2018 Mar;117:38-43. doi: 10.1016/j.lungcan.2018.01.007. Epub 2018 Jan 12. — View Citation

Takada 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. — View Citation

Torre 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. — View Citation

Wen P, Wang TF, Li M, Yu Y, Zhou YL, Wu CL. Meta-analysis of prophylactic cranial irradiation or not in treatment of extensive-stage small-cell lung cancer: The dilemma remains. Cancer Radiother. 2020 Feb;24(1):44-52. doi: 10.1016/j.canrad.2019.10.001. Epub 2020 Feb 7. Review. — View Citation

Yu J, Ouyang W, Yang Y, Zhang X, Zhou Y, Zhang J, Xie C. Prophylactic cranial irradiation for extensive-stage small cell lung cancer: Analysis based on active brain MRI surveillance. Clin Transl Radiat Oncol. 2020 Sep 15;25:16-21. doi: 10.1016/j.ctro.2020.09.005. eCollection 2020 Nov. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory end point including biomarkers	To explore the correlation of PD-L1 expression in tumor tissue , TCR, ctDNA in peripheral blood and efficacy	1 year
Primary	Progression-free survival in the brain	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	1 year
Secondary	Progression-free survival (PFS)	The length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse	1 year
Secondary	Overall survival (OS)	The time from treatment to death from any cause	1 year
Secondary	Adverse events	The incidence and severity of adverse events related to treatments	1 year
Secondary	The cognitive function of the patient	Use the Montreal Cognitive Screening Scale (MoCA) to score, the total score is 30 points, =26 points are normal	1 year