The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJian Chen
About this trial
To observe the efficacy and toxicities of post-operative (R0/R1) proton radiotherapy for locally advanced primary thymus epithelial malignancies. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with stage II-III (Masaoka-Koga) thymus epithelial malignancies without a history of thoracic radiation therapy, who have undergone radical surgery and have a definite pathological diagnosis, and undergone surgery for R0 (no microscopic residual disease) or R1 (microscopic residual disease) resection, and have indication of postoperative radiation therapy.
Sign informed consent.
Between the ages of 18 and 70.
ECOG general status score of 0-2.
Disqualifiers
Complicated with other malignant tumors that have not been controlled.
Have large quantity of pleural 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
Proton radiotherapy
RadiationPatients who received R0 resection will receive 45GyE per 18 fractions proton irradiation. Patients who received R1 resection will receive 50GyE per 20 fractions proton irradiation. Patients with thymus cancer should receive combined platinum based chemotherapy (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin, paclitaxel combined with cisplatin / carboplatin / loplatin / nedaplatin, Docetaxel combined with cisplatin / carboplatin / loplatin / nedaplatin) for at least 4 cycles.
combined platinum based chemotherapy
Other interventioncombined platinum based chemotherapy
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Study armExperimental treatment 2 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
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.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 death caused by non-small cell lung cancer treated in this study, 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