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
1 other identifier
interventional
57
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started Aug 2015
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
December 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJanuary 20, 2021
January 1, 2021
4.8 years
April 13, 2016
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
2 years
Secondary Outcomes (4)
Overall Survival
2 years
Response Rate
2 years
rate of patients who develop local recurrence or distant recurrence
2 year
rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0
1 year
Study Arms (1)
split-course radiotherapy
EXPERIMENTALThe 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.
Interventions
split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f
weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hui Liu
Guangzhou, Guangdong, 510000, China
Related Publications (46)
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PMID: 35905860DERIVEDChen N, Li Q, Wang S, Xiong M, Luo Y, Wang B, Chen L, Lin M, Jiang X, Fang J, Guo S, Guo J, Hu N, Ai X, Wang D, Chu C, Liu F, Long H, Wang J, Qiu B, Liu H. Hypo-fractionated radiotherapy with concurrent chemotherapy for locoregional recurrence of non-small cell lung cancer after complete resection: A prospective, single-arm, phase II study (GASTO-1017). Lung Cancer. 2021 Jun;156:82-90. doi: 10.1016/j.lungcan.2021.04.020. Epub 2021 Apr 27.
PMID: 33933895DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui Liu, professor
Sun yat-sen universtiy cancer center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 13, 2016
First Posted
December 30, 2016
Study Start
August 1, 2015
Primary Completion
June 1, 2020
Study Completion
July 1, 2021
Last Updated
January 20, 2021
Record last verified: 2021-01