Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy

March 13, 2024 updated by: HAN GUANG, Hubei Cancer Hospital

Omitting CTV Radiotherapy for Locally Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Radiotherapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTV-omitted
CTV was omitted for the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.
Radiation: 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.
Active Comparator: CTV-delineated
CTV was delineated for the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
grade 2 or more pneumonitis
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
local/regional control rate
Time Frame: up to 12 months
up to 12 months
Progress free survival
Time Frame: up to 12 months
up to 12 months
grade 3 or more pneumonitis
Time Frame: up to 6 months
up to 6 months
grade 3 or more esophagitis
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hubei Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2024

Primary Completion (Estimated)

February 8, 2026

Study Completion (Estimated)

October 8, 2027

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMCTV-HC-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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