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Dose-painting Radiation for LA-NSCLC (DPRLC)

Primary Purpose

Non-small Cell Lung Cancer Stage III, Non-small Cell Lung Cancer Stage II

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dose-Painting Radiation
Sponsored by
Sichuan Cancer Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer Stage III focused on measuring radiotherapy, dose-painting radiation, non-small cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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;
  2. The age at the time of signing the informed consent form is between 18 and 75 years old;
  3. It is diagnosed as non-small cell lung cancer by histology, and is suitable for radical radiotherapy:
  4. Stage II-Ⅲ (AJCC 8th edition [Rice et al., 2017]) inoperable NSCLC patients (not medically suitable for surgery or refuse surgical intervention);
  5. Measurable lesions that meet the definition of RECISTv1.1;
  6. ECOG physical status ≤ 2;
  7. Survival expectancy ≥ 3 months;
  8. Hemoglobin ≥100g/L, WBC≥4×109/L, platelet ≥100×109/L (or follow the standards of each center);
  9. Liver function: ALT, AST<1.5 times the upper limit of normal (ULN), total bilirubin<1.5×ULN;
  10. Renal function: serum creatinine <1.5×ULN;
  11. Pulmonary function: FEV1>50%, the percentage of DLCO (lung diffusion function) measured value and predicted value>80% mild to moderate lung function impairment.
  12. The patient has good compliance with the treatment and follow-up.

Exclusion Criteria:

  1. There is evidence of distant metastasis (M1, AJCC 8th edition [Rice et al., 2017]);
  2. 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);
  3. Intolerance or resistance to the chemotherapy, targeted, and immunotherapy specified in the experimental protocol;
  4. Have received radiotherapy and surgical treatment;
  5. 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);
  6. A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.;
  7. Has suffered from other malignant tumors;
  8. Subjects who have received other drug trials within the past month;
  9. Pregnant or lactating women and women who refuse contraception during the treatment observation period;
  10. People with a history of severe allergies or idiosyncratic physique;
  11. Those with a history of severe lung or heart disease;
  12. Refusal or inability to sign the informed consent to participate in the trial;
  13. Drug or alcohol addicts;
  14. Personality or mental illness, lack of capacity for civil conduct or limited capacity for civil conduct.

Sites / Locations

  • Sichuan Cancer Hospital & InstituteRecruiting
  • Yunnan Cancer HospitalRecruiting
  • Chongqing university three Gorges hospitalRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assigned Interventions

Arm Description

Radiation therapy: Dose-painting radiation Systemic treatment: Choose a systemic treatment plan according to the patient's genetic testing status (1) Chemotherapy Squamous cell carcinoma: Paclitaxel 135mg/m2 D1 + Cisplatin 25mg/m2 D1-3, every 21 days, a total of 2-4 cycles. 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;

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
OS
OS(Overall survival) refers to the time from enrollment to the first recorded death due to any cause (whichever occurs first).
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.

Full Information

First Posted
August 25, 2021
Last Updated
September 1, 2021
Sponsor
Sichuan Cancer Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05031533
Brief Title
Dose-painting Radiation for LA-NSCLC
Acronym
DPRLC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer Stage III, Non-small Cell Lung Cancer Stage II
Keywords
radiotherapy, dose-painting radiation, non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assigned Interventions
Arm Type
Experimental
Arm Description
Radiation therapy: Dose-painting radiation Systemic treatment: Choose a systemic treatment plan according to the patient's genetic testing status (1) Chemotherapy Squamous cell carcinoma: Paclitaxel 135mg/m2 D1 + Cisplatin 25mg/m2 D1-3, every 21 days, a total of 2-4 cycles. 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;
Intervention Type
Radiation
Intervention Name(s)
Dose-Painting Radiation
Intervention Description
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: 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
Primary Outcome Measure Information:
Title
FPS
Description
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.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
ORR
Description
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
Time Frame
up to 3 years
Title
OS
Description
OS(Overall survival) refers to the time from enrollment to the first recorded death due to any cause (whichever occurs first).
Time Frame
up to 3 years
Title
HRQoL
Description
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.
Time Frame
up to 3 years
Other Pre-specified Outcome Measures:
Title
Prognostic Biomarkers
Description
The expression of lymphocyte subsets in peripheral blood, including CD3+ T cells, CD4+ T cells, CD8+ T cells, CD8+CD28+ T cells, CD8+CD28- T cells, Treg cells, NK cells, NKT cells, γδ T cells;
Time Frame
up to 8 weeks
Title
Prognostic Biomarkers
Description
The changing trend of various cytokines in radiotherapy, including IL-6, IL-1b, IL-9, TNF-a, TGF-β, IL-10, IL-21, etc.
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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. Exclusion Criteria: 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.; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiahua Lyu, Doctor
Phone
+86-17713539529
Email
winlttljh@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Li
Facility Information:
Facility Name
Sichuan Cancer Hospital & Institute
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Li, Doctor
Phone
86-18908178818
Email
litaoxmf@163.com
First Name & Middle Initial & Last Name & Degree
Jiahua Lyu, doctor
Facility Name
Yunnan Cancer Hospital
City
Kunming
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaoxiong Xia
Facility Name
Chongqing university three Gorges hospital
City
Wanzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shichuan Chang
Facility Name
General Hospital of Ningxia Medical University
City
Yingchuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ren Zhao
First Name & Middle Initial & Last Name & Degree
Yanyang Wang

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dose-painting Radiation for LA-NSCLC

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