Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy

NCT ID: NCT06020430

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-08
• Study Completion Date: 2027-10-08

Brief Summary

Radical radiotherapy is critical for locally advanced non small cell lung cancer(NSCLC ). Our previous sturdy indicated that patients who received induction immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis.Grade 2 or more pneumonitis patients 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 CTV radiation is feasible for patients undergoing concurrent radio-chemotherapy for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to induction 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

Non Small Cell Lung Cancer; Locally Advanced; Radiotherapy; Immunotherapy

Study Design

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

Study Groups

CTV-omitted

CTV was omitted for the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.

Group Type: EXPERIMENTAL

CTV omitted or delineated

Intervention Type: RADIATION

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

CTV-delineated

CTV was delineated for the radical radiotherapy for locally 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 induction therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radical radiotherapy group or CTV-delineated radiotherapy group.

Interventions

CTV omitted or delineated

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed non-small cell lung cancer;

2. stage IIIA or IIIB or IIIC according to the 8th edition of the TNM cancer staging system of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control（UICC);

3. inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy;

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

5. performance status 0-1;

6. measurable or evaluable lesions;

7. Survival expectancy is not less than 6 months;

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

Exclusion Criteria

1. tumor progress after induction with immunothearoy 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

Locations

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Guang Han, PhD

Role: primary

hg7913@hotmail.com

+86 13886048178

Other Identifiers

OMCTV-HC-001

Identifier Type: -

Identifier Source: org_study_id