Overview
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.
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.
- For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
- For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
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 1.510^9/L;
- platelet 8010^9/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 ALT2.5 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.