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
Qualifiers
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
Treatments tested in this trial
- Proton radiotherapy
- combined platinum based chemotherapy
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Jian Chen
Lead sponsor
Shanghai Proton and Heavy Ion Center
Sponsor institution
Source ClinicalTrials.gov