Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer

Launched by XINQIAO HOSPITAL OF CHONGQING · Jun 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed, specifically focusing on whether it's safe to skip a part of the radiation treatment called the clinical target volume (CTV). The researchers want to see if this adjusted treatment can still be effective while reducing the side effects that can come with traditional radiation therapy, such as severe lung and throat issues. In earlier studies, they found that this approach did not negatively affect how long patients lived or how long they lived without the cancer worsening.

To be eligible for this trial, participants should be between 18 and 80 years old, have advanced NSCLC that is not operable, and a good overall health status (specifically, a performance status level of 0 or 1). They should also expect to live for at least 12 weeks and meet certain health criteria based on blood tests. Participants will receive radiation treatment followed by immunotherapy, which helps the body's immune system fight the cancer. It's important to note that women who can become pregnant must use reliable birth control during the trial, and there are several health conditions that would disqualify someone from participating. Overall, the trial aims to find a safer and effective treatment method for patients facing this challenging diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • •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 \~80 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 Criteria:
• • 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