Stage III Non-small-cell Lung CancerNCT05331833
Omitting Clinical Target Volume of Unresectable Stage III Non-small-cell Lung Cancer.
An observational study of Stage III Non-small-cell Lung Cancer, run by Jianguo Sun.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage III Non-small-cell Lung Cancer
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with advanced (Stage IIIa or IIIb) NSCLC that was histologically or cytologically inoperable.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Stage III Non-small-cell Lung Cancer
- Being tested
- 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.
- Keywords
- PET-CT, IMRT, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Radiation
| Study group | Role | What they receive |
|---|---|---|
| study group | CTV-omitted IMRT under PET-CT guidance Receives: 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 Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
incidence of radiation respiratory events or esophagitis with grade 3 or higher
incidence of radiation respiratory events or esophagitis with grade 3 or higher
Measured: after radiation therapy，up to 1 year
Secondary outcomes (4)
objective response rate
objective response rate
Measured: through study completion，up to 12 weeks
locate control rate
Measured: through study completion，up to 12 weeks
progression-free survival
Measured: through study completion，up to 12 weeks
overall survival
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Aug 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Non-small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianguo Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331833
- Sponsor's protocol ID
- XQonc-018
- Status last verified
- Aug 2022
- First submitted
- 29 Mar 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omitting Clinical Target Volume Under PET-CT Guidance in Unresectable Stage III Non-small-cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT05331833
- Acronym / sponsor ID
- XQonc-018
- Conditions
- Stage III Non-small-cell Lung Cancer
- Keywords
- PET-CT, IMRT, NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Jianguo SunUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | 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.CTV-omitted IMRT under PET-CT guidance |
| control group | – | 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.CTV-delineated IMRT under PET-CT guidance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced (Stage IIIa or IIIb) NSCLC that was histologically or cytologically inoperable.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | control group, study group |
Primary outcome
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
4 secondary outcomes
objective response rate
Time frame: through study completion，up to 12 weeks
locate control rate
Time frame: through study completion，up to 12 weeks
progression-free survival
Time frame: through study completion，up to 12 weeks
overall survival
Time frame: through study completion, an average of 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage III Non-small-cell Lung Cancer, run by Jianguo Sun.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of radiation respiratory events or esophagitis with grade 3 or higher (time frame: after radiation therapy，up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.