Back to resultsSBRT Compared With IMRT Concurrently With Chemotherapy in Treating Patients With LS-SCLC
Primary Purpose
Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SBRT
IMRT
EP
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Limited-stage small cell lung cancer, Stereotactic body radiation therapy, Intensity modulated radiation therapy, Radiation, Chemotherapy
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
Sites / Locations
- Daping Hospital, Third Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GROUP 1
GROUP 2
Arm Description
SBRT plus EP
IMRT plus EP
Outcomes
Primary Outcome Measures
progression-free survival
Secondary Outcome Measures
Overall survival
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Tumor response rate
Full Information
NCT ID
NCT02738723
First Posted
March 25, 2016
Last Updated
April 10, 2016
Sponsor
Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02738723
Brief Title
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Limited-stage small cell lung cancer, Stereotactic body radiation therapy, Intensity modulated radiation therapy, Radiation, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GROUP 1
Arm Type
Experimental
Arm Description
SBRT plus EP
Arm Title
GROUP 2
Arm Type
Active Comparator
Arm Description
IMRT plus EP
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
40 Gy for each patient. Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks.
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
EP
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
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 Outcome Measure Information:
Title
Overall survival
Time Frame
From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
the first date of treatment to 3 months after the last dose of study drug
Title
Tumor response rate
Time Frame
the ratio between the number of responders and number of patients assessable for tumor response，assessed up to 1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xueqin Yang, PHD
Phone
86-23-68757151
Email
yangxueqin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueqin Yang, PHD
Organizational Affiliation
Daping Hospital, Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueqin Yang, PH.D.
Phone
86-23-68757151
Email
yangxueqin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xueqin Yang, PH.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25416052
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.
Results Reference
background
PubMed Identifier
9920950
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.
Results Reference
background
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SBRT Compared With IMRT Concurrently With Chemotherapy in Treating Patients With LS-SCLC
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