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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC; Radiotherapy; Immunotherapy; Intensity Modulated Radiation Therapy
• Intervention / Treatment: Radiation: IMRT+adjuvant immunotherapy

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: jianguo sun, Phd; Phone Number: 0086 023-68774490; Email: sunjg09@aliyun.com
• Study Contact Backup: Name: tianxiang cui; Phone Number: 8613206196552

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; CTV-omitted IMRT+adjuvant immunotherapy	Radiation: IMRT+adjuvant immunotherapy; 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; CTV-delineated IMRT+adjuvant immunotherapy	Radiation: IMRT+adjuvant immunotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from randomization to death from any cause	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: immunotherapy; IMRT; CTV
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: XQonc-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No