Back to resultsPrimary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Primary Purpose
Advanced Non-Small Cell Squamous Lung Cancer, Radiotherapy, Immunotherapy
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CTV omitted or delineated
Sponsored by
About this trial
This is an interventional prevention trial for Advanced Non-Small Cell Squamous Lung Cancer focused on measuring omitting CTV
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed advanced non-small cell lung cancer (according to the 8th edition of the TNM cancer staging system of AJCC and UICC); After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend); Age 18 to 80 years old, performance status 0-1; measurable or evaluable lesions; Survival expectancy is not less than 6 months; adequate cardiac, pulmonary, renal, and hepatic and bone marrow function Exclusion Criteria: tumor progress after therapy with immunotherapy and chemotherapy EGFR, ALK, or ROS1 mutation; Previous thoracic radiotherapy; grade 2 or more immune-related adverse events after induction immunotherapy Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ); Pregnant or lactating women undergoing other clinical trials; Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes; Patients with HIV positive and undergoing antiviral therapy; Active tuberculosis
Sites / Locations
- Hubei Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CTV-omitted
CTV-delineated
Arm Description
CTV was omitted for primary tumor radiotherapy for advanced NSCLC who responded to therapy with immunotherapy and chemotherapy.
CTV was delineated for primary tumor radiotherapy for advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.
Outcomes
Primary Outcome Measures
grade 2 or more pneumonitis
Secondary Outcome Measures
local/regional control rate
Progress free survival
grade 3 or more pneumonitis
grade 3 or more esophagitis
Full Information
NCT ID
NCT06037733
First Posted
September 7, 2023
Last Updated
September 7, 2023
Sponsor
Hubei Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06037733
Brief Title
Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Official Title
Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 8, 2023 (Anticipated)
Primary Completion Date
October 8, 2025 (Anticipated)
Study Completion Date
October 8, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hubei Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this randomized study is to investigate pneumonitis, local tumor control, and survival outcomes of primary tumor radiotherapy omitting CTV for patients with advanced NSCLC responded to immunotherapy and chemotherapy
Detailed Description
Studies have confirmed that systemic therapy combined with primary tumor radiotherapy can improve symptoms and prolong survival of advanced NSCLC. Our previous sturdy indicated that patients who received immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis. Patients suffered grade 2 or more pneumonitis have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for patients treated with immunotherapy and radiotherapy. According to retrospective and prospective studies, omitting primary tumor CTV radiation therapy showed no reduction in local control and survival for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to therapy with immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain better immune function which will facilitate the immunotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-Small Cell Squamous Lung Cancer, Radiotherapy, Immunotherapy
Keywords
omitting CTV
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CTV-omitted
Arm Type
Experimental
Arm Description
CTV was omitted for primary tumor radiotherapy for advanced NSCLC who responded to therapy with immunotherapy and chemotherapy.
Arm Title
CTV-delineated
Arm Type
Active Comparator
Arm Description
CTV was delineated for primary tumor radiotherapy for advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.
Intervention Type
Radiation
Intervention Name(s)
CTV omitted or delineated
Intervention Description
Patients who responded to the therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radiotherapy group or CTV-delineated radiotherapy group.
Primary Outcome Measure Information:
Title
grade 2 or more pneumonitis
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
local/regional control rate
Time Frame
up to 12 months
Title
Progress free survival
Time Frame
up to 12 months
Title
grade 3 or more pneumonitis
Time Frame
up to 6 months
Title
grade 3 or more esophagitis
Time Frame
up to 6 months
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:
Histologically or cytologically confirmed advanced non-small cell lung cancer (according to the 8th edition of the TNM cancer staging system of AJCC and UICC);
After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);
Age 18 to 80 years old, performance status 0-1;
measurable or evaluable lesions;
Survival expectancy is not less than 6 months;
adequate cardiac, pulmonary, renal, and hepatic and bone marrow function
Exclusion Criteria:
tumor progress after therapy with immunotherapy and chemotherapy
EGFR, ALK, or ROS1 mutation;
Previous thoracic radiotherapy;
grade 2 or more immune-related adverse events after induction immunotherapy
Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);
Pregnant or lactating women
undergoing other clinical trials;
Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;
Patients with HIV positive and undergoing antiviral therapy;
Active tuberculosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guang Han, PhD
Phone
+86 13886048178
Email
hg7913@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Han, PhD
Organizational Affiliation
Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
12. IPD Sharing Statement
Learn more about this trial
Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy
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