Clinical trial NCT02738723: SBRT Compared With IMRT Concurrently With Chemotherapy in Treating Patients With LS-SCLC
Official title: Stereotactic Body Radiation Therapy Compared With Intensity Modulated Radiation Therapy Concurrently With Chemotherapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Limited-stage small cell lung cancer
Stereotactic body radiation therapy
Intensity modulated radiation therapy
Radiation
Chemotherapy
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present, the aim of this study is to evaluate the efficacy and safety of stereotactic body radiation therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell lung cancer


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of SCLC
* 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:

* Non small cell lung cancer and carcinoid
* 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

Primary outcomes:
measure: progression-free survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: the first date of treatment to 3 months after the last dose of study drug
measure: Tumor response rate
timeFrame: the ratio between the number of responders and number of patients assessable for tumor response，assessed up to 1 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital, Third Military Medical University
name: Xueqin Yang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1056/NEJM199901283400403.