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

• Sponsor: Hubei Cancer Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06037733
• Collaborator: (none)
• Enrollment: 134
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 2.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Non-Small Cell Squamous Lung Cancer; Radiotherapy; Immunotherapy	Radiation: CTV omitted or delineated	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy
• Anticipated Study Start Date: Oct 8, 2023
• Anticipated Primary Completion Date: Oct 8, 2025
• Anticipated Study Completion Date: Oct 8, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTV-omitted CTV was omitted for primary tumor radiotherapy for advanced NSCLC who responded to therapy with immunotherapy and chemotherapy.	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.
Active Comparator: CTV-delineated CTV was delineated for primary tumor radiotherapy for advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.	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.

Outcome Measures

Primary Outcome Measures

1. grade 2 or more pneumonitis [up to 6 months]

Secondary Outcome Measures

1. local/regional control rate [up to 12 months]

2. Progress free survival [up to 12 months]

3. grade 3 or more pneumonitis [up to 6 months]

4. grade 3 or more esophagitis [up to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hubei Cancer Hospital	Wuhan	Hubei	China	430079

Sponsors and Collaborators

• Hubei Cancer Hospital

Investigators

• Principal Investigator: Guang Han, PhD, Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HAN GUANG, Director of the department of Radiotherapy Oncology, Hubei Cancer Hospital
• ClinicalTrials.gov Identifier: NCT06037733
• Other Study ID Numbers: OMCTV-HC-002
• First Posted: Sep 14, 2023
• Last Update Posted: Sep 14, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by HAN GUANG, Director of the department of Radiotherapy Oncology, Hubei Cancer Hospital: omitting CTV
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Sep 14, 2023