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

• Sponsor: Xinqiao Hospital of Chongqing (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05909137
• Collaborator: (none)
• Enrollment: 60
• Anticipated Duration (Months): 27

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immunotherapy; Intensity Modulated Radiation Therapy; Radiotherapy; NSCLC	Radiation: IMRT+adjuvant immunotherapy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Feasibility of Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Progression-free survival [through study completion，up to 12 weeks]

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

2. radiation respiratory events or esophagitis with grade 3 or higher [after radiation therapy，up to 1 year]

Secondary Outcome Measures

1. Overall survival [through study completion, an average of 2 year]

   Time from randomization to death from any cause

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xinqiao Hospital of Chongqing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianguo Sun, Deputy director of oncology department，clinical professor, Xinqiao Hospital of Chongqing
• ClinicalTrials.gov Identifier: NCT05909137
• Other Study ID Numbers: XQonc-022
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jianguo Sun, Deputy director of oncology department，clinical professor, Xinqiao Hospital of Chongqing: IMRT; immunotherapy; CTV
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung; Immunomodulating Agents

Study Results

No Results Posted as of Jun 18, 2023