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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer Using Hypofractionated Technique.

Conditions
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Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy

Intervention / Treatment
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* Radiation: thoracic irradiation
* Drug: Concurrent chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thoracic irradiation<br>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. | Radiation: thoracic irradiation<br>* 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.<br>Drug: Concurrent chemotherapy<br>* For centrally located recurrent tumors, concurrent chemotherapy consists of weekly docetaxel and nedaplatin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control |  | 2 Years | 
| Incidence of Grade ≥3 pulmonary toxicity/esophageal toxicity |  | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypofraction, loco-regionally recurrent non-small cell lung cancer, thoracic irradiation