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

  • STATUS
    Recruiting
  • participants needed
    35
  • sponsor
    Sun Yat-sen University
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Updated on 19 February 2024
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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.

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.

Details
Condition Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy
Age 18years - 75years
Treatment thoracic irradiation, Concurrent chemotherapy
Clinical Study IdentifierNCT04275687
SponsorSun Yat-sen University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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