Back to resultsOnce-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
q.d. RT
b.i.d.RT
etoposide and cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small cell lung cancer, Radiotherapy, Dose fractionation
Eligibility Criteria
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.
Sites / Locations
- Sun yat-sen university cancer center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
q.d. RT
b.i.d.RT
Arm Description
q.d. RT (65 Gy in 26 fractions) to the chest and concurrent etoposide and cisplatin
b.i.d.RT (45Gy in 30 fractions) to the chest and concurrent etoposide and cisplatin
Outcomes
Primary Outcome Measures
progression-free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT02337712
First Posted
January 9, 2015
Last Updated
January 25, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02337712
Brief Title
Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small cell lung cancer, Radiotherapy, Dose fractionation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
q.d. RT
Arm Type
Experimental
Arm Description
q.d. RT (65 Gy in 26 fractions) to the chest and concurrent etoposide and cisplatin
Arm Title
b.i.d.RT
Arm Type
Active Comparator
Arm Description
b.i.d.RT (45Gy in 30 fractions) to the chest and concurrent etoposide and cisplatin
Intervention Type
Radiation
Intervention Name(s)
q.d. RT
Intervention Description
65 Gy in 26 fractions
Intervention Type
Radiation
Intervention Name(s)
b.i.d.RT
Intervention Description
45 Gy in 30 fractions
Intervention Type
Drug
Intervention Name(s)
etoposide and cisplatin
Intervention Description
etoposide and cisplatin concurrent with radiotherapy
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Professor
Organizational Affiliation
Sun yat-sen universtiy cancer center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun yat-sen university cancer center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
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Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer
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