Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy
Conditions
Keywords
loco-regionally recurrent non-small cell lung cancer, thoracic irradiation, hypofraction
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 peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions. 2. 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.
Interventions
RADIATIONthoracic irradiation
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.
DRUGConcurrent chemotherapy
For centrally located recurrent tumors, concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Local Control | 2 Years |
| Incidence of Grade ≥3 pulmonary toxicity/esophageal toxicity | 1 Year |
Countries
China
Contacts
Primary ContactBo Qiu, Ph.D
Backup ContactHui Liu, Prof.
Outcome results
None listed