Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy

Immunotherapy Clinical Trial

Official title:

Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037733
• Other study ID #: OMCTV-HC-002
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: October 8, 2027

Study information

• Verified date: March 2024
• Source: Hubei Cancer Hospital
• Contact: Guang Han, PhD
• Phone: +86 13886048178
• Email: hg7913[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: October 8, 2027
• Est. primary completion date: March 13, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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);

2. After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);

3. Age 18 to 80 years old, performance status 0-1;

4. measurable or evaluable lesions;

5. Survival expectancy is not less than 6 months;

6. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function

Exclusion Criteria:

1. tumor progress after therapy with immunotherapy and chemotherapy

2. EGFR, ALK, or ROS1 mutation;

3. Previous thoracic radiotherapy;

4. grade 2 or more immune-related adverse events after induction immunotherapy

5. Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);

6. Pregnant or lactating women

7. undergoing other clinical trials;

8. Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;

9. Patients with HIV positive and undergoing antiviral therapy;

10. Active tuberculosis

Related Conditions & MeSH terms

• Advanced Non-Small Cell Squamous Lung Cancer
• Immunotherapy
• Lung Neoplasms
• Radiotherapy

Intervention

Radiation:
• CTV omitted or delineated
Patients who responded to the therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radiotherapy group or CTV-delineated radiotherapy group.

Locations

Country	Name	City	State
China	Hubei Cancer Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hubei Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	grade 2 or more pneumonitis		up to 6 months
Secondary	local/regional control rate		up to 12 months
Secondary	Progress free survival		up to 12 months
Secondary	grade 3 or more pneumonitis		up to 6 months
Secondary	grade 3 or more esophagitis		up to 6 months