Omitting Clinical Target Volume of Unresectable Stage III Non-small-cell Lung Cancer.

August 29, 2022 updated by: Jianguo Sun

Omitting Clinical Target Volume Under PET-CT Guidance in Unresectable Stage III Non-small-cell Lung Cancer.

About 20-30% of patients with stage III non-small cell lung cancer (NSCLC) are unresectable and definitive concurrent radiochemotherapy is the standard care. Intensity-modulated radiation therapy (IMRT) is a new radiotherapy technology, including gross tumor volume (GTV), clinical target volume (CTV), internal target volume (ITV), and planning target volume (PTV) as delineated target volumes. The treatment failure of local advanced NSCLC is mainly caused by local recurrence accounted for 50% and distant metastasis accounted for 50%. Local recurrence occurs both within the radiation field and outside the radiation field. Elective nodal irradiation (ENI) was designed before, however the adverse events (AEs) was not satisfactory. Afterwards, involved field radiotherapy (IFRT) showed that a reduced irradiation field did not increase local recurrence, and lowered the AEs Thus, IFRT has been broadly used in clinical work instead of ENI. IFRT still has disadvantages, including the risk of radiation respiratory events and radiation esophagitis, can the irradiation area be further reduced to reduce adverse reactions without affecting the efficacy? Positron emission tomography -computed tomography (PET-CT) can accurately assess primary tumor and metastatic lymph nodes in NSCLC patients better than CT . A meta-analysis of 39 clinical studies showed that the median sensitivity and specificity of PET-CT for the detection of lymph node involvement were 85% and 90%, respectively, while those of CT alone were only 61% and 79%, respectively. The radiotherapy application of PET-CT in image acquisition can ensure the delineation of both primary tumor and mediastinal lymph node metastasis. Under this condition, can the radiation field be further reduced to lower the dose to normal tissue and radiotherapy-associated AEs? A dosimetry study showed that when a dose of 60 Gy was given to the primary tumor and positive mediastinal lymph nodes, even if the CTV was omitted, a dose of 50 Gy was sufficient to cover the subclinical area.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A dosimetry study showed that when a dose of 60 Gy was given to the primary tumor and positive mediastinal lymph nodes, even if the CTV was omitted, a dose of 50 Gy was sufficient to cover the subclinical area.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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 ~75 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
study group
CTV-omitted IMRT under PET-CT guidance
Radiation: The enrollment was randomly (1:1) assigned into the study group with CTV-omitted IMRT under PET-CT guidance and the control group with CTV-delineated IMRT using a random number table.
control group
CTV-delineated IMRT under PET-CT guidance
Radiation: The enrollment was randomly (1:1) assigned into the study group with CTV-omitted IMRT under PET-CT guidance and the control group with CTV-delineated IMRT using a random number table.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence of radiation respiratory events or esophagitis with grade 3 or higher
Time Frame: after radiation therapy，up to 1 year
incidence of radiation respiratory events or esophagitis with grade 3 or higher
after radiation therapy，up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: through study completion, an average of 2 year
through study completion, an average of 2 year
objective response rate
Time Frame: through study completion，up to 12 weeks
objective response rate
through study completion，up to 12 weeks
locate control rate
Time Frame: through study completion，up to 12 weeks
through study completion，up to 12 weeks
progression-free survival
Time Frame: through study completion，up to 12 weeks
through study completion，up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jianguo Sun

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XQonc-018

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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