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Trial Title:
The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor
NCT ID:
NCT06311968
Condition:
Thymus Epithelial Tumor
Proton Radiotherapy
Radiation Toxicity
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Proton radiotherapy
Description:
Patients 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.
Arm group label:
Study arm
Intervention type:
Other
Intervention name:
combined platinum based chemotherapy
Description:
combined platinum based chemotherapy
Arm group label:
Study arm
Summary:
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.
Detailed description:
Patients 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. The primary endpoint was progression-free survival and toxicities, and the
secondary endpoint was overall survival and cause-specific survival.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- The expected survival is at least 6 months.
- Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x
109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung function: FEV1>25%,
DLCO>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and
cerebrovascular diseases, peripheral vascular diseases, serious chronic heart
disease and other complications that may affect radiotherapy.4). Adequate liver
function: total bilirubin <1.5 times the upper limit of normal value, and AST, ALT<2
times the upper limit of normal value. 5). Adequate renal function: serum creatinine
≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml /min,
and urinary protein <2+. Patients with a baseline urinary protein level of 2+ or
more should have a 24-hour urine collection and evidence of a 24-hour urinary
protein level of 1g or less.
Exclusion Criteria:
- 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.
- Cardiac pacemakers or other internal metal prosthesis implants that may be affected
by high-energy radiation or may affect the dose distribution to the radiation target
area.
- HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy,
but because of concomitant disease cannot receive antiviral therapy. Active stage of
syphilis.
- A history of mental illness may hinder the completion of treatment.
- With serious comorbidity that may interfere with radiotherapy, including: (a) Acute
infectious diseases or acute active phase of chronic infection. b) Unstable angina
pectoris, congestive heart failure, myocardial infarction that has been hospitalized
in the past 6 months. c) Exacerbations of chronic obstructive pulmonary disease or
other respiratory conditions requiring hospitalization. d) Severely impaired immune
function. e) Diseases with excessive sensitivity to radiation such as ataxia
telangiectasia. f) Other diseases that may affect particle radiotherapy.
- Other circumstances that the physician considers inappropriate to participate in
clinical study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Proton and Heavy Ion Center
Address:
City:
Shanghai
Zip:
201513
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Li
Phone:
86-21-38296678
Email:
jing.li@sphic.org.cn
Contact backup:
Last name:
Kun Liu
Phone:
86-21-38296678
Email:
kun.liu@sphic.org.cn
Investigator:
Last name:
Jian Chen, MD
Email:
Principal Investigator
Investigator:
Last name:
Jingfang Mao, PHD
Email:
Principal Investigator
Investigator:
Last name:
Kai-liang Wu, PHD
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
February 28, 2027
Lead sponsor:
Agency:
Jian Chen
Agency class:
Other
Source:
Shanghai Proton and Heavy Ion Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06311968