- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03006575
Study of Split-course Chemoradiotherapy For Postoperative Locoregional Recurrence Of Non-small Cell Lung Cancer
A Prospective, Randomized, Phase Ⅱ Study of Split-course Chemoradiotherapy For Locoregional Recurrence Of Non-small Cell Lung Cancer After Surgical Resection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This Phase II randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection.
Patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with split-course thoracic radiotherapy of 40-51 Gy/10-17 fractions and 15-24 Gy/5-8 fractions administered in the first and second courses, respectively, with one-month break. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. Progression-free survival will be calculated using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Bo Qiu, attending
- Phone Number: +86-020-87343031
- Email: qiubo@sysucc.org.cn
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510000
- Recruiting
- Hui Liu
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologic confirmation of NSCLC.
- Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Postoperative locoregional recurrence including ipsilateral hemithorax and the mediastinum.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Previously treated with chemotherapy or treatment-naive
- No previous chest radiotherapy, immunotherapy or biotherapy
- Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
- Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
- Bilirubin ≤1.5 times UNL, AST(SGOT)≤2.5 times UNL ,ALT(SGPT)≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
- Forced expiratory volume at one second (FEV1) >0.8 L
- Coagulation tests within normal limits
- patients and their family signed the informed consents
Exclusion Criteria:
- Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
- Second primary carcinoma of the lung
- Contraindication for chemotherapy
- Malignant pleural or pericardial effusion.
- Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dos
- Women who has the probability of pregnancy without contraception
- Tendency of hemorrhage
- In other clinical trials within 30 days
- Addicted in drugs or alcohol, AIDS patients
- Uncontrollable seizure or psychotic patients without self-control ability
- Severe allergy or idiosyncrasy
- Not suitable for this study judged by researchers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: split-course radiotherapy
The radiotherapy is delivered using simultaneous integrated boost (SIB)-IMRT.
Patients are irradiation at a palliative dose at the initial course: 40-51Gy/10-17f to PTV-GTV.
The disease is re-evaluated one month after the end of the initial course using CT.
The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost.
At the second course, the tumor is repositioned and scanned.
The residual tumor was then treated with the second course of radiotherapy.
A dose of 15-24 Gy/5-8f is delivered to the residue tumor.
Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
|
weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: 2 years
|
2 years
|
Response Rate
Time Frame: 2 years
|
2 years
|
rate of patients who develop local recurrence or distant recurrence
Time Frame: 2 year
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2 year
|
rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GASTO-1017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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