Clinical Study of Carbon Ion Radiotherapy Combined With Chemotherapy for Thymic Epithelial Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJian Chen
About this trial
To observe the efficacy of carbon ion radiotherapy combined with chemotherapy in the treatment of inoperable locally advanced or advanced (all visible lesions can be included in the radiation target area in this treatment) primary thymic epithelial tumor who have no thorax radiotherapy histroy. The patients will receive 72GyE/18fractions of carbon ion radiotherapy. Combined with platinum-containing schemes (including etoposide combined with cisplatin or carboplatin or loplatin or nedaplatin, paclitaxel combined with cisplatin or carboplatin or loplatin or nedaplatin, etc.); Docetaxel combined with cisplatin or carboplatin or loplatin or nedaplatin) for at least 4 cycles. Progression-free survival, local control rate, overall survival and toxicity were calculated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with inoperable locally advanced or advanced thymic epithelial tumor who have been confirmed pathologically, and have not received thoracic radiation therapy before coming to our hospital, and have radiologically evaluable lesions, and all visible lesions can be included in the radiation target area during this treatment.
Between the ages of 18 and 70.
Sign the informed consent.
ECOG general status score of 0-2 .
Disqualifiers
Complicated with other malignant tumors that have not been controlled.
With large quantity of pleural effusion or pericardial effusion.
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 patients received 72GyE/18 doses of carbon ion radiotherapy.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Study armExperimental treatment 1 intervention
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 monthsSecondary 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 months2
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.3
Incidence of Treatment-induced Adverse Events
Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, 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.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