Clinical trial NCT05909137: Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Official title: Feasibility of Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Immunotherapy
Intensity Modulated Radiation Therapy
Radiotherapy
NSCLC
Keywords: IMRT
immunotherapy
CTV
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced (Stage IIIa or IIIb) NSCLC that was histologically or cytologically inoperable.

Brief 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.


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

Primary outcomes:
measure: Progression-free survival
timeFrame: through study completion，up to 12 weeks
measure: radiation respiratory events or esophagitis with grade 3 or higher
timeFrame: after radiation therapy，up to 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
Study officials:
References: