Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer
NCT ID: NCT02337712
Last Updated: 2021-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
198 participants
INTERVENTIONAL
2015-01-31
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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q.d. RT
q.d. RT (65 Gy in 26 fractions) to the chest and concurrent etoposide and cisplatin
q.d. RT
65 Gy in 26 fractions
etoposide and cisplatin
etoposide and cisplatin concurrent with radiotherapy
b.i.d.RT
b.i.d.RT (45Gy in 30 fractions) to the chest and concurrent etoposide and cisplatin
b.i.d.RT
45 Gy in 30 fractions
etoposide and cisplatin
etoposide and cisplatin concurrent with radiotherapy
Interventions
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q.d. RT
65 Gy in 26 fractions
b.i.d.RT
45 Gy in 30 fractions
etoposide and cisplatin
etoposide and cisplatin concurrent with radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Hui Liu
Professor
Principal Investigators
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Hui Liu, Professor
Role: PRINCIPAL_INVESTIGATOR
Sun yat-sen universtiy cancer center
Locations
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Sun yat-sen university cancer center
Guangzhou, Guangdong, China
Countries
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References
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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(R) radiation therapy for small-cell lung cancer. Am J Clin Oncol. 2013 Apr;36(2):206-13. doi: 10.1097/COC.0b013e31827e5523.
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. doi: 10.1200/JCO.2007.11.5303.
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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. doi: 10.1097/JTO.0b013e318074bbf5.
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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. doi: 10.1200/JCO.1993.11.2.336.
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Qiu B, Li Q, Liu J, Huang Y, Pang Q, Zhu Z, Yang X, Wang B, Chen L, Fang J, Lin M, Jiang X, Guo S, Guo J, Wang D, Liu F, Chu C, Huang X, Xie C, Liu H. Moderately Hypofractionated Once-Daily Compared With Twice-Daily Thoracic Radiation Therapy Concurrently With Etoposide and Cisplatin in Limited-Stage Small Cell Lung Cancer: A Multicenter, Phase II, Randomized Trial. Int J Radiat Oncol Biol Phys. 2021 Oct 1;111(2):424-435. doi: 10.1016/j.ijrobp.2021.05.003. Epub 2021 May 13.
Other Identifiers
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2014-FXY-037
Identifier Type: -
Identifier Source: org_study_id
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