Status:
COMPLETED
Omitting Clinical Target Volume of Unresectable Stage III Non-small-cell Lung Cancer.
Lead Sponsor:
Jianguo Sun
Conditions:
Stage III Non-small-cell Lung Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
About 20-30% of patients with stage III non-small cell lung cancer (NSCLC) are unresectable and definitive concurrent radiochemotherapy is the standard care. Intensity-modulated radiation therapy (IMR...
Detailed Description
A dosimetry study showed that when a dose of 60 Gy was given to the primary tumor and positive mediastinal lymph nodes, even if the CTV was omitted, a dose of 50 Gy was sufficient to cover the subclin...
Eligibility Criteria
Inclusion
- Patients with advanced (Stage IIIA or IIIB AJCC 7) NSCLC that was histologically or cytologically inoperable
- ECOG whole body status (performancestatus,PS) level 0 or 1
- The estimated survival time is more than 12 weeks, 18 \~75 years old
- Laboratory results within 2 weeks prior to radiotherapy met the following criteria: ① Neutrophil count \> 1,500/ MCL Heathko-Pilot Oncology Research Fund; ② Platelet \> 50,000/ MCL; ③ Total bilirubin \< 1.5 times of the normal upper limit value; ④AST(SGOT)/ALT(SGPT) \< 2.5 times of the normal upper limit; ⑤ Serum creatinine \< 1.5 times of the normal upper limit value; ⑥ The results of coagulation function examination were within the normal range
- Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results are negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug
- Understand and voluntarily sign written informed consent
- The investigator judged that the patient had good compliance
Exclusion
- Malignant pleural/pericardial effusions, previous thoracic radiotherapy or chemotherapy
- Uncontrolled concurrent diseases, including but not limited to symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, uncontrolled diabetic blood sugar, arrhythmia, mental illness or social condition, etc.
- Pregnant or nursing women
- The patient has no history of intracranial hemorrhage or spinal cord hemorrhage
- HIV-positive patients receiving combination antiretroviral therapy
- Active tuberculosis
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- Prior allogeneic stem cell or solid organ transplantation
- Researchers determine other conditions that may affect the conduct of clinical studies and the determination of their findings
Key Trial Info
Start Date :
August 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05331833
Start Date
August 1 2016
End Date
December 31 2020
Last Update
August 30 2022
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