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

NCT06037733 | Recruiting

• 1 other identifier: OMCTV-HC-002
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

omitting CTV

Outcome Measures

Primary Outcomes (1)

• grade 2 or more pneumonitis

  up to 6 months

Secondary Outcomes (4)

• local/regional control rate

  up to 12 months

• Progress free survival

  up to 12 months

• grade 3 or more pneumonitis

  up to 6 months

• grade 3 or more esophagitis

  up to 6 months

Study Arms (2)

CTV-omitted

EXPERIMENTAL

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

Radiation: CTV omitted or delineated

CTV-delineated

ACTIVE COMPARATOR

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

Radiation: CTV omitted or delineated

Interventions

CTV omitted or delineated 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-omitted

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Study Officials

• Guang Han, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Han, PhD

CONTACT

+86 13886048178; hg7913@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of Radiotherapy Oncology

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: March 13, 2024
• Primary Completion: March 13, 2026
• Study Completion (Estimated): October 8, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CN (1)