Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age75+
SponsorJian Chen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older than 75 years old.
ECOG general status score of 0-2.
Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-4N1-3M0, stage IIb-IIIc (AJCC/UICC 8th edition).
Medically inoperable, or patient refuses surgery.
Disqualifiers
Patient with squamous cell carcinoma was treated with bevacizumab before carbon ion radiotherapy.
Complicated with other malignant tumors that have not been controlled.
Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
Chest radiation therapy or radioactive particle implantation history.
Trial design
Design model
Single group
Treatments tested in this trial
carbon ion radiotherapy
RadiationThe 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
Other interventiontargeted therapy
single regimen chemotherapy in sequence with radiotherapy
Other interventionsingle regimen chemotherapy in sequence with radiotherapy
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: Study armExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Disease progression-free survival rate
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 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.2
Incidence of Treatment-induced Adverse Events
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, 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.Secondary outcomes
1
Local control rate
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 local disease progression, assessed up to 100 months.2
Cause-specific survival rate
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 first documented death caused by non-small cell lung cancer treated in this study, assessed up to 100 months.3
Overall survival rate
Overall survival rate was defined from the start of carbon ion radiotherapy till the date of death 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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jian Chen
Lead sponsor
Shanghai Proton and Heavy Ion Center
Sponsor institution
Source ClinicalTrials.gov