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Trial Title:
Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy
NCT ID:
NCT06020430
Condition:
Non Small Cell Lung Cancer
Locally Advanced
Radiotherapy
Immunotherapy
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
omitting CTV
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
CTV omitted or delineated
Description:
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.
Arm group label:
CTV-delineated
Arm group label:
CTV-omitted
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Guang Han, PhD
Phone:
+86 13886048178
Email:
hg7913@hotmail.com
Start date:
February 8, 2024
Completion date:
October 8, 2027
Lead sponsor:
Agency:
Hubei Cancer Hospital
Agency class:
Other
Source:
Hubei Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06020430
