Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy Clinical Trial
Official title:
Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer Using Hypofractionated Technique.
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.
| Status | Recruiting |
| Enrollment | 35 |
| Est. completion date | February 1, 2025 |
| Est. primary completion date | February 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Sun Yat-sen University | Guangzhou |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Yat-sen University |
China,
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* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival | 2 years | ||
| Secondary | Local Control | 2 Years | ||
| Secondary | Incidence of Grade =3 pulmonary toxicity/esophageal toxicity | 1 Year |