NCT06020430Recruiting
Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Omitting CTV Radiotherapy for Locally Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Radiotherapy
Source: ClinicalTrials.gov · Last updated 15 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 28 Aug 2023
- Start date
- 8 Feb 2024
- Primary completion date
- 8 Feb 2026
- Lead sponsor
- Hubei Cancer Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06020430
What you commit to
- Study type: Interventional
- Planned participants: 134
- From 8 Feb 2024 to the primary completion date, 8 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- tumor progress after induction with immunothearoy and chemotherapy
- Previous thoracic radiotherapy;
- grade 2 or more immune-related adverse events after induction immunotherapy
Other illness
- Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);
- 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
Lab values
- EGFR, ALK, or ROS1 mutation;
Other
- Pregnant or lactating women
- undergoing other clinical trials;
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.