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

NCT05909137 | Not Yet Recruiting

• 1 other identifier: XQonc-022
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immunotherapy; Intensity Modulated Radiation Therapy; Radiotherapy; NSCLC

Keywords

IMRT; immunotherapy; CTV

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  The time between randomization and the first occurrence of disease progression or die

  through study completion，up to 12 weeks

• radiation respiratory events or esophagitis with grade 3 or higher

  after radiation therapy，up to 1 year

Secondary Outcomes (1)

• Overall survival

  through study completion, an average of 2 year

Study Arms (2)

study group

CTV-omitted IMRT+adjuvant immunotherapy

Radiation: IMRT+adjuvant immunotherapy

control group

CTV-delineated IMRT+adjuvant immunotherapy

Radiation: IMRT+adjuvant immunotherapy

Interventions

IMRT+adjuvant immunotherapy RADIATION

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.

control group; study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Central Study Contacts

jianguo sun, Phd

CONTACT

023-68774490; sunjg09@aliyun.com

tianxiang cui

CONTACT

8613206196552

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of oncology department，clinical professor

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share