Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy Compared With Twice-daily Radiotherapy in Limited Small-cell Lung Cancer Treated Concurrently With Cisplatin and Etoposide

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02337712
• Other study ID #: 2014-FXY-037
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

This Phase II randomized study is to determine whether once-daily (qd)simultaneous modulated accelerated thoracic radiotherapy resulted in better survival than twice-daily(bid) RT for patients with limited-stage small-cell lung cancer (LD-SCLC).

All patients receive four to six cycles of etoposide and cisplatin (EP) every 3 weeks. Thoracic RT is initiated with cycle 1-3 of chemotherapy. Qd RT includes the delivery of 65 Gy in 26 fractions delivered on weekdays for a total of 33 days. Bid RT includes the delivery of 45 Gy in 30 fractions delivered on weekdays for a total of 19 days. After the chest RT and the last cycle of EP, prophylactic cranial irradiation is administered to those patients with a complete or partial remission.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 198
• Est. completion date: December 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Radiation:
• q.d. RT
65 Gy in 26 fractions
• b.i.d.RT
45 Gy in 30 fractions

Drug:
• etoposide and cisplatin
etoposide and cisplatin concurrent with radiotherapy

Locations

Country	Name	City	State
China	Sun yat-sen university cancer center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (16)

Bogart JA, Herndon JE 2nd, Lyss AP, Watson D, Miller AA, Lee ME, Turrisi AT, Green MR; Cancer and Leukemia Group B study 39808. 70 Gy thoracic radiotherapy is feasible concurrent with chemotherapy for limited-stage small-cell lung cancer: analysis of Cancer and Leukemia Group B study 39808. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):460-8. — View Citation

Chen 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. — View Citation

Choi 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. — View Citation

Fan TY, Xing J, Lu J, Liu TH, Xu M, Zhang YJ, Shao Q, Li JB, Yu JM. Phase I/II study of induction chemotherapy plus concurrent chemotherapy and SMART-IMRT-based radiotherapy in locoregionally-advanced nasopharyngeal cancer. Oncol Lett. 2013 Mar;5(3):889-895. Epub 2013 Jan 15. — View Citation

Giuliani ME, Lindsay PE, Sun A, Bezjak A, Le LW, Brade A, Cho J, Leighl NB, Shepherd FA, Hope AJ. Locoregional failures following thoracic irradiation in patients with limited-stage small cell lung carcinoma. Radiother Oncol. 2012 Feb;102(2):263-7. doi: 10.1016/j.radonc.2011.12.009. Epub 2012 Jan 28. — View Citation

Hu 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. — View Citation

Kong 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® radiation therapy for small-cell lung cancer. Am J Clin Oncol. 2013 Apr;36(2):206-13. doi: 10.1097/COC.0b013e31827e5523. Review. — View Citation

Liao ZX, Komaki RR, Thames HD Jr, Liu HH, Tucker SL, Mohan R, Martel MK, Wei X, Yang K, Kim ES, Blumenschein G, Hong WK, Cox JD. Influence of technologic advances on outcomes in patients with unresectable, locally advanced non-small-cell lung cancer receiving concomitant chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):775-81. doi: 10.1016/j.ijrobp.2009.02.032. Epub 2009 Jun 8. — View Citation

Miller AA, Wang XF, Bogart JA, Hodgson LD, Rocha Lima CM, Radford JE, Vokes EE, Green MR; Cancer and Leukemia Group B (CALGB). Phase II trial of paclitaxel-topotecan-etoposide followed by consolidation chemoradiotherapy for limited-stage small cell lung cancer: CALGB 30002. J Thorac Oncol. 2007 Jul;2(7):645-51. — View Citation

Murray N, Coy P, Pater JL, Hodson I, Arnold A, Zee BC, Payne D, Kostashuk EC, Evans WK, Dixon P, et al. Importance of timing for thoracic irradiation in the combined modality treatment of limited-stage small-cell lung cancer. The National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1993 Feb;11(2):336-44. — View Citation

Roof KS, Fidias P, Lynch TJ, Ancukiewicz M, Choi NC. Radiation dose escalation in limited-stage small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2003 Nov 1;57(3):701-8. — View Citation

Shirvani SM, Juloori A, Allen PK, Komaki R, Liao Z, Gomez D, O'Reilly M, Welsh J, Papadimitrakopoulou V, Cox JD, Chang JY. Comparison of 2 common radiation therapy techniques for definitive treatment of small cell lung cancer. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):139-47. doi: 10.1016/j.ijrobp.2013.05.040. — View Citation

Socinski 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. Review. — View Citation

Turrisi 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. — View Citation

Xia B, Chen GY, Cai XW, Zhao JD, Yang HJ, Fan M, Zhao KL, Fu XL. Is involved-field radiotherapy based on CT safe for patients with limited-stage small-cell lung cancer? Radiother Oncol. 2012 Feb;102(2):258-62. doi: 10.1016/j.radonc.2011.10.003. Epub 2011 Nov 5. — View Citation

Yee D, Hanson J, Butts C, Reiman A, Joy A, Smylie M, Fenton D, Chu Q, Roa W. Phase I dose escalation trial of hypofractionated limited-field external beam thoracic radiotherapy for limited-stage small cell carcinoma of the lung. Radiother Oncol. 2010 Jul;96(1):78-83. doi: 10.1016/j.radonc.2010.05.013. Epub 2010 Jun 11. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		2 years