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

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

NCT ID: NCT05909137

Condition: Immunotherapy
Intensity Modulated Radiation Therapy
Radiotherapy
NSCLC

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Immunomodulating Agents

Conditions: Keywords:
IMRT
immunotherapy
CTV

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Radiation
Intervention name: IMRT+adjuvant immunotherapy
Description: The enrollment was randomly (1:1) assigned into the study group with CTV-omitted IMRT and the control group with CTV-delineated IMRT using a random number table.
Arm group label: control group
Arm group label: study group

Summary: Simultaneous radiotherapy followed by adjuvant immunotherapy is the standard treatment modality of unresectable stage III NSCLC. Our preliminary study confirmed that the treatment of CTV-omitted IMRT regimen did not compromise the PFS or OS and significantly reduced the incidence of severe radiation pneumonia and radiation esophagitis. The purpose of this study was to observe the role of radiotherapy modalities that omit CTV in the context of immunotherapy for NSCLC.

Criteria for eligibility:

Study pop:
Patients with advanced (Stage IIIa or IIIb) NSCLC that was histologically or cytologically inoperable.

Sampling method: Non-Probability Sample
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

Gender: All

Gender based: Yes

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: September 2024

Completion date: December 2026

Lead sponsor:
Agency: Xinqiao Hospital of Chongqing
Agency class: Other

Source: Xinqiao Hospital of Chongqing

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05909137