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

ConditionsImmunotherapyIntensity Modulated Radiation TherapyRadiotherapyNSCLC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXinqiao Hospital of Chongqing

About this trial

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

This trial accepts healthy volunteers

Qualifiers

•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

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: study group1 intervention
Group B: control group1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

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

Time frame
through study completion，up to 12 weeks
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 from randomization to death from any cause

Time frame
through study completion, an average of 2 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinqiao Hospital of Chongqing

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: