Omitting radiation for advanced lung cancer patients who responded to treatment
Omitting CTV Radiotherapy for Locally Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Radiotherapy
This study is testing whether skipping radiation for patients with advanced lung cancer who have responded well to initial treatment can help reduce side effects while still keeping the cancer under control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hubei Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06020430 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of omitting clinical target volume (CTV) radiation in patients with locally advanced non-small cell lung cancer (NSCLC) who have responded to induction therapy with immunotherapy and chemotherapy. The aim is to reduce the incidence of pneumonitis, a common side effect of radiotherapy, while maintaining effective local control of the cancer. By optimizing the radiotherapy approach, the study seeks to enhance immune function and improve patient outcomes. Participants will be monitored for their response to treatment and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are patients with stage IIIA, IIIB, or IIIC non-small cell lung cancer who have shown a positive response to prior immunotherapy and chemotherapy.
Not a fit: Patients with tumor progression after induction therapy or those with specific genetic mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced side effects and improved quality of life for patients undergoing treatment for advanced lung cancer.
How similar studies have performed: Previous studies have indicated that omitting CTV radiation is feasible for similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wuhan, Hubei
- Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.