Back to resultsA Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer
Primary Purpose
Carcinoma of Lung, Small Cell, Limited Stage
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
hyperfractionated radiation therapy for both arms
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma of Lung
Eligibility Criteria
Inclusion Criteria:
- Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage
- Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included.
- The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy.
- Karnofsky performance status was ≥ 80.
- Forced expiratory volume at 1 second (FEV1) ≥ 1 L.
- Had measurable or assessable disease.
- Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L.
- Serum creatine and bilirubin < 1.5 × the upper normal limit (UNL), aminotransferase < 2 × UNL.
- Weight loss was less than 10% within 6 months before diagnosis.
- Written informed consent was required from all patients.
Exclusion Criteria:
- Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.
Sites / Locations
- Sun Yat-Sen University, Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study arm
control arm
Arm Description
For patients who are randomized to study arm, (i.e. to irradiate the post-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the post-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm. Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles. Radiotherapy will be administered with cycle 3 chemotherapy（1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks）
For patients who are randomized to control arm, (i.e. to irradiate the pre-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the pre-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm. Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles. Radiotherapy will be administered with cycle 3 chemotherapy (1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks).
Outcomes
Primary Outcome Measures
local-regional progression
Secondary Outcome Measures
overall survival
Full Information
NCT ID
NCT01731548
First Posted
November 14, 2012
Last Updated
January 21, 2013
Sponsor
Zhejiang Cancer Hospital
Collaborators
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01731548
Brief Title
A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer
Official Title
Omitting Elective Nodal Irradiation and Irradiating Post-induction Versus Pre-induction Chemotherapy Tumor Extent for Limited-stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
Collaborators
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We hypothesized that the local control for both arms were not statistically significant, when irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted for both arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of Lung, Small Cell, Limited Stage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study arm
Arm Type
Experimental
Arm Description
For patients who are randomized to study arm, (i.e. to irradiate the post-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the post-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm.
Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles.
Radiotherapy will be administered with cycle 3 chemotherapy（1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks）
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
For patients who are randomized to control arm, (i.e. to irradiate the pre-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the pre-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm.
Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles.
Radiotherapy will be administered with cycle 3 chemotherapy (1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks).
Intervention Type
Radiation
Intervention Name(s)
hyperfractionated radiation therapy for both arms
Intervention Description
1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms
Primary Outcome Measure Information:
Title
local-regional progression
Time Frame
at least 6 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
at least 1 year
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:
Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage
Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included.
The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy.
Karnofsky performance status was ≥ 80.
Forced expiratory volume at 1 second (FEV1) ≥ 1 L.
Had measurable or assessable disease.
Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L.
Serum creatine and bilirubin < 1.5 × the upper normal limit (UNL), aminotransferase < 2 × UNL.
Weight loss was less than 10% within 6 months before diagnosis.
Written informed consent was required from all patients.
Exclusion Criteria:
Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Chen, MD
Phone
+86 18758875572
Email
gzcm@263.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Chen, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen University, Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Liu, MD. PHD
Phone
086-020-87343033
Email
liuhui@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Yong Bao, MD
Phone
086-020-87343504
Email
baoyong@sysucc.org.cn
12. IPD Sharing Statement
Learn more about this trial
A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer
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