Status:
UNKNOWN
Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.
Detailed Description
This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique. 1. For periph...
Eligibility Criteria
Inclusion
- loco-regionally recurrent NSCLC after thoracic radiotherapy (confirmed by pathology or continuous enhanced CT imaging);
- chemotherapy, targeted or immunotherapy are allowed before enrollment;
- \>=6 months from previous chest radiotherapy;
- presence of measurable disease according to RECIST criteria;
- ECOG performance score is 0-1;
- organ and bone marrow functions meet the following criteria:
- forced expiratory volume in 1 second (FEV1) ≥ 0.8L;
- percentage-predicted single-breath carbon monoxide diffusing capacity (DLCO %) \> 60%;
- absolute neutrophil count ≥1.5×10\^9/L;
- platelet ≥80×10\^9/L;
- hemoglobin ≥9.0g/dL;
- serum creatinine clearance was ≥50 mL/min calculated based on the Cockcroft-Gault formula
- serum bilirubin ≤1.5 times normal upper limit (ULN)
- AST and ALT≤2.5 times ULN
Exclusion
- previous or concurrent with other malignant tumors, except for non-melanoma of the skin or carcinoma in situ of the cervix;
- loco-regional recurrence with distant metastasis;
- any other disease or condition contradicted to radiotherapy (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
- women who are pregnant or breastfeeding, women who have not undergone a pregnancy test (within 14 days before first administration), and women who are pregnant;
- pregnancy, lactation, or fertility but no contraceptive measures;
- those with bleeding tendency;
- participate in other clinical trials within 30 days before enrollment;
- drug and other drug addiction, chronic alcoholism and AIDS patients;
- having uncontrollable seizures or loss of self-control due to psychosis;
- a history of severe allergies;
- participants considered unfit to participate in this study.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04275687
Start Date
March 1 2020
End Date
February 1 2025
Last Update
February 21 2020
Active Locations (1)
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1
Sun Yat-sen University
Guangzhou, China, 510000