Back to resultsEarly Versus Late Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
early CCRT
late CCRT
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring limited disease
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed small-cell lung cancer
- limited disease status
- with evaluable disease
- 18 years or older
- ECOG performance status 0,1,2
- expected survival time should be 12 weeks or longer
- Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min
- Written informed consent form
Exclusion Criteria:
- Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
- Patients with active infection requiring antibiotics
- Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
- Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
- previous history of chemotherapy or radiotherapy
Sites / Locations
- Keunchil Park
- Asan Medican Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
late CCRT
Early CCRT
Arm Description
radiotherapy start on day one of the third cycle of chemotherapy
Radiotherapy start on day 1 of 1st cycle of chemotherapy
Outcomes
Primary Outcome Measures
complete response rate
Secondary Outcome Measures
overall survival
objective response rate
Progression-free survival
toxicity by NCI common toxicity version 2.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01125995
Brief Title
Early Versus Late Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
Official Title
A Randomized Phase III Trial for Timing of Radiation in Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy and toxicity of different timing of concurrent chemoradiation in the treatment of limited disease status 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 disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
late CCRT
Arm Type
Active Comparator
Arm Description
radiotherapy start on day one of the third cycle of chemotherapy
Arm Title
Early CCRT
Arm Type
Experimental
Arm Description
Radiotherapy start on day 1 of 1st cycle of chemotherapy
Intervention Type
Radiation
Intervention Name(s)
early CCRT
Intervention Description
patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 & Cisplatin 70mg/m2 D1.
radiotherapy start from day 1 of 1st chemotherapy cycle and complete 5250cGy/25fraction (daily one fraction, 210cGy).
Intervention Type
Radiation
Intervention Name(s)
late CCRT
Intervention Description
patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 & Cisplatin 70mg/m2 D1.
radiotherapy start from day 1 of the third cycle of EP chemotherapy and complete 5250cGy/25fraction (daily one fraction, 210cGy).
Primary Outcome Measure Information:
Title
complete response rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
36 months
Title
objective response rate
Time Frame
6 months
Title
Progression-free survival
Time Frame
36 months
Title
toxicity by NCI common toxicity version 2.0
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically confirmed small-cell lung cancer
limited disease status
with evaluable disease
18 years or older
ECOG performance status 0,1,2
expected survival time should be 12 weeks or longer
Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min
Written informed consent form
Exclusion Criteria:
Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
Patients with active infection requiring antibiotics
Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
previous history of chemotherapy or radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keunchil Park
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keunchil Park
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medican Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Early Versus Late Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
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