Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05909137

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Progression-free survival

    Time frame: 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

    Time frame: after radiation therapy,up to 1 year

Secondary outcomes

  1. Overall survival

    Time frame: through study completion, an average of 2 year

    Time from randomization to death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

jianguo sun, Phd

CONTACT

[email protected]

023-68774490 ext. 0086

tianxiang cui

CONTACT

8613206196552

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.