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

NCT ID: NCT06037733

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-13
• Study Completion Date: 2027-10-08

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.

Conditions

Advanced Non-Small Cell Squamous Lung Cancer; Radiotherapy; Immunotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CTV-omitted

CTV was omitted for primary tumor radiotherapy for advanced NSCLC who responded to therapy with immunotherapy and chemotherapy.

Group Type: EXPERIMENTAL

CTV omitted or delineated

Intervention Type: RADIATION

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

CTV-delineated

CTV was delineated for primary tumor radiotherapy for advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.

Group Type: ACTIVE_COMPARATOR

CTV omitted or delineated

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hubei Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

HAN GUANG

Director of the department of Radiotherapy Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guang Han, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guang Han, PhD

Role: CONTACT

hg7913@hotmail.com

+86 13886048178

Facility Contacts

Han Guang, MD

Role: primary

Other Identifiers

OMCTV-HC-002

Identifier Type: -

Identifier Source: org_study_id