Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

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.