NCT06020430

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Feb 2024Oct 2027

First Submitted

Initial submission to the registry

August 28, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 8, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2026

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2027

Expected
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

August 28, 2023

Last Update Submit

March 13, 2024

Conditions

Non Small Cell Lung CancerLocally AdvancedRadiotherapyImmunotherapy

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

Radiation: CTV omitted or delineated

CTV-delineated

ACTIVE COMPARATOR

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

Interventions

CTV omitted or delineatedRADIATION

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-delineatedCTV-omitted

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed non-small cell lung cancer;
  • 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);
  • inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy;
  • After ≥2 cycles of induction chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);
  • 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 induction with immunothearoy 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

August 28, 2023

First Posted

August 31, 2023

Study Start

February 8, 2024

Primary Completion

February 8, 2026

Study Completion (Estimated)

October 8, 2027

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

CN(1)