Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201513, China
Location status: Recruiting
NCT Number: NCT06311981
To observe the effect and toxicity of carbon ion radiotherapy on local advanced non-small cell lung cancer over 75 years old patients. Systemic therapy could be targeted therapy, chemotherapy or immunotherapy.
Interested in participating?
Request Info75 year and older
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 201513, China
Location status: Recruiting
The patient will receive carbon ion radiotherapy with 70Gy per 20 fractions. Patients with genetic mutations (including but not limited to EGFR, ALK, etc.) should receive targeted therapy as their systemic therapy. For patients who are not suitable for targeted therapy, we recommend single regimen chemotherapy in sequence with radiotherapy. The drugs include etoposide, platinum (carboplatin, cisplatin, nedaplatin or loplatin), vinorelbine, paclitaxel (including liposome paclitaxel and albumin paclitaxel), docetaxel, pemetrexel, gemcitabine, etc. If there is no contraindication to PD-1/PD-L1 immunotherapy, it can be combined with immunotherapy, such as Pembrolizumab. For patients who cannot tolerate chemotherapy, PD-1/PD-L1 immunotherapy is recommended. The progression-free survival rate, toxicity, local control rate, cause-specific survival rate and overall survival rate were observed with regular follow-up after treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient will receive carbon ion radiotherapy with 70Gy per 20 fractions. Patients with genetic mutations (including but not limited to EGFR, ALK, etc.) should receive targeted therapy as their systemic therapy. For patients who are not suitable for targeted therapy, we recommend single regimen chemotherapy in sequence with radiotherapy. The drugs include etoposide, platinum (carboplatin, cisplatin, nedaplatin or loplatin), vinorelbine, paclitaxel (including liposome paclitaxel and albumin paclitaxel), docetaxel, pemetrexel, gemcitabine, etc. If there is no contraindication to PD-1/PD-L1 immunotherapy, it can be combined with immunotherapy, such as Pembrolizumab. For patients who cannot tolerate chemotherapy, PD-1/PD-L1 immunotherapy is recommended. The progression-free survival rate, toxicity, local control rate, cause-specific survival rate and overall survival rate were observed with regular follow-up after treatment.
targeted therapy
single regimen chemotherapy in sequence with radiotherapy
Time frame: From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up.
Time frame: From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months.
Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.
Time frame: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months.
Local control rate was defined from the start of carbon ion radiotherapy till the date of local failure or the last follow-up
Time frame: From date of radiotherapy started until the date of first documented death caused by non-small cell lung cancer treated in this study, assessed up to 100 months.
Cause-specific survival rate was defined from the start of carbon ion radiotherapy till the date of death caused by non-small cell lung cancer treated in this study or the last follow-up
Time frame: From date of radiotherapy started until the date of death from any cause, assessed up to 100 months.
Overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up.
Interested in participating?
Request InfoJian Chen
Other
A Prospective Phase II Clinical Study of Carbon Ion Radiotherapy for Locally Advanced Non-small Cell Lung Cancer in the Older Adult
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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