Non-small Cell Lung Cancer Stage IIIDPRLCNCT05031533
Dose-painting Radiation for LA-NSCLC
A study testing Dose-Painting Radiation in people with Non-small Cell Lung Cancer Stage III and Non-small Cell Lung Cancer Stage II, run by Sichuan Cancer Hospital and Research Institute at 4 sites in China.
Trial summary
The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage III, Non-small Cell Lung Cancer Stage II
- What is being tested?
- Dose-Painting Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2021to Dec 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient or the legal representative of the patient can sign a written informed consent, and can understand and agree to follow the research requirements;
- The age at the time of signing the informed consent form is between 18 and 75 years old;
- It is diagnosed as non-small cell lung cancer by histology, and is suitable for radical radiotherapy:
- Stage II-Ⅲ (AJCC 8th edition [Rice et al., 2017]) inoperable NSCLC patients (not medically suitable for surgery or refuse surgical intervention);
- Measurable lesions that meet the definition of RECISTv1.1;
- ECOG physical status ≤ 2;
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- Survival expectancy ≥ 3 months;
- Hemoglobin ≥100g/L, WBC≥4×109/L, platelet ≥100×109/L (or follow the standards of each center);
- Liver function: ALT, AST<1.5 times the upper limit of normal (ULN), total bilirubin<1.5×ULN;
- Renal function: serum creatinine <1.5×ULN;
- Pulmonary function: FEV1>50%, the percentage of DLCO (lung diffusion function) measured value and predicted value>80% mild to moderate lung function impairment.
- The patient has good compliance with the treatment and follow-up.
Who cannot join
- There is evidence of distant metastasis (M1, AJCC 8th edition [Rice et al., 2017]);
- There is pleural effusion, pericardial effusion or ascites that is not clinically controlled and requires repeated drainage or medical intervention (within 2 weeks before randomization);
- Intolerance or resistance to the chemotherapy, targeted, and immunotherapy specified in the experimental protocol;
- Have received radiotherapy and surgical treatment;
- There were other active malignant tumors ≤ 2 years before enrollment, except for the specific cancers under study in this study and locally recurring cancers that have been cured (eg, resected basal cell or squamous cell skin cancer, superficial Bladder cancer, carcinoma in situ of the cervix or breast);
- A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.;
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- Has suffered from other malignant tumors;
- Subjects who have received other drug trials within the past month;
- Pregnant or lactating women and women who refuse contraception during the treatment observation period;
- People with a history of severe allergies or idiosyncratic physique;
- Those with a history of severe lung or heart disease;
- Refusal or inability to sign the informed consent to participate in the trial;
- Drug or alcohol addicts;
- Personality or mental illness, lack of capacity for civil conduct or limited capacity for civil conduct.
Trial locations and contacts
4 sites in 1 country.
Tao Li contact
China4 sites, 4 recruiting
- Recruiting
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, 610041
Tao Li, Doctor, 86-18908178818, litaoxmf@163.com
Jiahua Lyu, doctor
- Recruiting
Yunnan Cancer Hospital
Kunming
Yaoxiong Xia
- Recruiting
Chongqing university three Gorges hospital
Wanzhou
Shichuan Chang
- Recruiting
General Hospital of Ningxia Medical University
Yingchuan
Ren Zhao
Yanyang Wang
About this study
Official title: A Prospective Study on the Efficacy, Safety and Immune Effects of Dose-painting Radiation for Locally Advanced Non-small Cell Lung Cancer(LA-NSCLC)
The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.
Read the detailed description
The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.
The primary endpoint is PFS. Secondary points contains ORR, OS, HRQoL, and safety.
- Being tested
- Dose-Painting Radiation
- Keywords
- radiotherapy, dose-painting radiation, non-small cell lung cancer
- 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.
Dose-Painting RadiationRadiation
Radiation therapy:
- Delineation of target area: The primary tumor is delineated into different target areas according to the anatomical position of the tumor, including the central area tumor GTV-Tcentral and GTV-Tperipheral.
- Exposure dose:
- GTV-Tcentral: 2.0～2.5Gy/f, bid, 10-13d, physical dose 40-65Gy 2) GTV-Tperipheral: 3.0～4.0Gy/f, bid, 10-13d, physical dose 60-104Gy 3) GTV-N (mediastinal lymph node): 2.0Gy/f, bid, 10-13d, physical dose 40-52Gy
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Experimental | Radiation therapy: Dose-painting radiation
Systemic treatment: Choose a systemic treatment plan according to the patient's genetic testing status
(1) Chemotherapy
1. Squamous cell carcinoma: Paclitaxel 135mg/m2 D1 + Cisplatin 25mg/m2 D1-3, every 21 days, a total of 2-4 cycles.
2. Non-squamous cell carcinoma (adenocarcinoma, large cell carcinoma): Pemetrexed 500mg/m2 d1 + Cisplatin 75 mg/m2 d1-3, a total of 2-4 cycles.
(2) Targeted therapy: According to the patient's genetic testing status, molecular targeted therapy such as EGFR-TKI and ALK inhibitors can be selected; (3) Immunotherapy: According to the patient's genetic testing status, immunotherapy such as PD1/PD-L1 inhibitors can be selected; Receives: Radiation: Dose-Painting Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
FPS
progression-free survival (PFS) refers to the time from enrollment to the first recording of disease progression as determined by RECISTv1.1, or to death due to any cause (whichever occurs first). PFS will be analyzed in the ITT analysis set.
Measured: up to 3 years
Secondary outcomes (3)
ORR
Objective response rate, according to RECISTv1.1, the proportion of patients with CR or PR was determined. If the patient has not undergone a post-baseline assessment, it is considered unremission
Measured: up to 3 years
OS
OS(Overall survival) refers to the time from enrollment to the first recorded death due to any cause (whichever occurs first).
Measured: up to 3 years
HRQoL
HRQoL uses EORTCQLQ-C30 to assess the overall health of patients. The post-baseline score of the treatment group was studied, and the score changes from the baseline were summarized descriptively.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Jan 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI TAO, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031533
- Sponsor's protocol ID
- SCCHEC202108
- Acronym
- DPRLC
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Efficacy, Safety and Immune Effects of Dose-painting Radiation for Locally Advanced Non-small Cell Lung Cancer(LA-NSCLC)
- ClinicalTrials.gov ID
- NCT05031533
- Acronym / sponsor ID
- DPRLC / SCCHEC202108
- Keywords
- radiotherapy, dose-painting radiation, non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Sep 2021 (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.
The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.
Detailed description
The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.
The primary endpoint is PFS. Secondary points contains ORR, OS, HRQoL, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Experimental | Radiation: Dose-Painting RadiationRadiation therapy: Dose-painting radiation Systemic treatment: Choose a systemic treatment plan according to the patient's genetic testing status (1) Chemotherapy 1. Squamous cell carcinoma: Paclitaxel 135mg/m2 D1 + Cisplatin 25mg/m2 D1-3, every 21 days, a total of 2-4 cycles. 2. Non-squamous cell carcinoma (adenocarcinoma, large cell carcinoma): Pemetrexed 500mg/m2 d1 + Cisplatin 75 mg/m2 d1-3, a total of 2-4 cycles. (2) Targeted therapy: According to the patient's genetic testing status, molecular targeted therapy such as EGFR-TKI and ALK inhibitors can be selected; (3) Immunotherapy: According to the patient's genetic testing status, immunotherapy such as PD1/PD-L1 inhibitors can be selected; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The patient or the legal representative of the patient can sign a written informed consent, and can understand and agree to follow the research requirements;
- The age at the time of signing the informed consent form is between 18 and 75 years old;
- It is diagnosed as non-small cell lung cancer by histology, and is suitable for radical radiotherapy:
- Stage II-Ⅲ (AJCC 8th edition [Rice et al., 2017]) inoperable NSCLC patients (not medically suitable for surgery or refuse surgical intervention);
- Measurable lesions that meet the definition of RECISTv1.1;
Key exclusion criteria (14 listed)
- There is evidence of distant metastasis (M1, AJCC 8th edition [Rice et al., 2017]);
- There is pleural effusion, pericardial effusion or ascites that is not clinically controlled and requires repeated drainage or medical intervention (within 2 weeks before randomization);
- Intolerance or resistance to the chemotherapy, targeted, and immunotherapy specified in the experimental protocol;
- Have received radiotherapy and surgical treatment;
- There were other active malignant tumors ≤ 2 years before enrollment, except for the specific cancers under study in this study and locally recurring cancers that have been cured (eg, resected basal cell or squamous cell skin cancer, superficial Bladder cancer, carcinoma in situ of the cervix or breast);
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 |
|---|---|---|
| Dose-Painting RadiationRadiation therapy: 1. Delineation of target area: The primary tumor is delineated into different target areas according to the anatomical position of the tumor, including the central area tumor GTV-Tcentral and GTV-Tperipheral. 2. Exposure dose: 1) GTV-Tcentral: 2.0～2.5Gy/f, bid, 10-13d, physical dose 40-65Gy 2) GTV-Tperipheral: 3.0～4.0Gy/f, bid, 10-13d, physical dose 60-104Gy 3) GTV-N (mediastinal lymph node): 2.0Gy/f, bid, 10-13d, physical dose 40-52Gy | Radiation | Assigned Interventions |
Primary outcome
FPS
Time frame: up to 3 years
progression-free survival (PFS) refers to the time from enrollment to the first recording of disease progression as determined by RECISTv1.1, or to death due to any cause (whichever occurs first). PFS will be analyzed in the ITT analysis set.
3 secondary outcomes
ORR
Time frame: up to 3 years
OS
Time frame: up to 3 years
HRQoL
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Tao Li contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dose-Painting Radiation in people with Non-small Cell Lung Cancer Stage III and Non-small Cell Lung Cancer Stage II, run by Sichuan Cancer Hospital and Research Institute at 4 sites in China.
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 12 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiahua Lyu, Doctor (+86-17713539529, winlttljh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FPS (time frame: up to 3 years). 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 2 Sep 2021.