SBRT Compared With IMRT Concurrently With Chemotherapy in Treating Patients With LS-SCLC
NCT ID: NCT02738723
Last Updated: 2016-04-14
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
50 participants
INTERVENTIONAL
2016-01-31
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GROUP 1
SBRT plus EP
SBRT
40 Gy for each patient. Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks.
EP
Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks. Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.
GROUP 2
IMRT plus EP
IMRT
45 Gy for each patient，Accelerated twice-daily thoracic radiotherapy involved the administration of 1.5 Gy in 30 treatments over a period of three weeks.
EP
Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks. Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.
Interventions
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SBRT
40 Gy for each patient. Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks.
IMRT
45 Gy for each patient，Accelerated twice-daily thoracic radiotherapy involved the administration of 1.5 Gy in 30 treatments over a period of three weeks.
EP
Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks. Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.
Eligibility Criteria
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Inclusion Criteria
* limited-stage disease is defined as disease confined to the ipsilateral hemithorax, which can be safely encompassed within a radiation field
* No prior chemotherapy, or radiotherapy
* Performance status of 0, 1, 2 on the ECOG criteria.
* At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
* Adequate hematologic (neutrophil count \>= 1,500/uL, platelets \>= 100,000/uL), hepatic (transaminase =\< upper normal limit(UNL)x2.5, bilirubin level =\< UNLx1.5), and renal (creatinine =\< UNL) function
* If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment.
Exclusion Criteria
* Supraclavicular lymphadenopathy
* Inability to comply with protocol or study procedures.
* Moderate and severe ventilation dysfunction
* Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Pregnant or breast-feeding.
* Enrollment in other study within 30 days
18 Years
70 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Xueqin Yang
Prof.
Principal Investigators
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Xueqin Yang, PHD
Role: PRINCIPAL_INVESTIGATOR
Daping Hospital, Third Military Medical University
Locations
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Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Li C, Xiong Y, Zhou Z, Peng Y, Huang H, Xu M, Kang H, Peng B, Wang D, Yang X. Stereotactic body radiotherapy with concurrent chemotherapy extends survival of patients with limited stage small cell lung cancer: a single-center prospective phase II study. Med Oncol. 2014 Dec;31(12):369. doi: 10.1007/s12032-014-0369-x. Epub 2014 Nov 22.
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. doi: 10.1056/NEJM199901283400403.
Other Identifiers
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STIM
Identifier Type: -
Identifier Source: org_study_id
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