Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor

Radiotherapy Side Effect Clinical Trial

Official title:

Prospective Phase II Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymic Epithelial Malignant Tumor Received R2 Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311955
• Other study ID #: SPHIC-TR-THLC2023-06
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2024
• Est. completion date: February 28, 2029

Study information

• Verified date: March 2024
• Source: Shanghai Proton and Heavy Ion Center
• Contact: Jing Li
• Phone: 86-21-38296678
• Email: jing.li[@]sphic.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To observe the efficacy and toxicities of heavy ion radiation therapy for locally advanced or advanced primary thymic epithelial malignant tumor received R2 resection. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival.

Description:

The patients will receive 72GyE per 18 fractions of carbon ion radiotherapy. Patients with thymus cancer should be combined with platinum-based regimen (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin; paclitaxel combined with cisplatin or 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 local relapse-free survival, overall survival and cause-specific survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: February 28, 2029
• Est. primary completion date: February 28, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with stage II-IV (Masaoka-Koga) thymus epithelial malignancies without a history of thoracic radiotherapy who had undergone radical surgery (R2 resection, visible residual tumor) and had a definite pathological diagnosis.

• 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.

• Pregnancy (confirmed by serum or urine ß-HCG test) or lactation period.

• 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.

Related Conditions & MeSH terms

• Radiotherapy Side Effect
• Thymic Epithelial Tumor

Intervention

Radiation:
• Carbon ion radiotherapy
The patients will receive 72GyE per 18 fractions of carbon ion radiotherapy. Patients with thymus cancer should be combined with platinum-based regimen (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin; paclitaxel combined with cisplatin or 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 local relapse-free survival, overall survival and cause-specific survival.

Other:
• combined with platinum-based regimen
combined with platinum-based regimen

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jian Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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	Local-progression free survival rate	Local-progression free survival rate was defined from the start of carbon ion radiotherapy till the date of local progression or the last follow-up.	From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months.
Secondary	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.	From date of radiotherapy started until the date of death from any cause, assessed up to 100 months.
Secondary	Cause-specific survival rate	Cause-specific survival rate was defined from the start of carbon ion radiotherapy till the date of death caused by thymus tumor treated in this study or the last follow-up.	From date of radiotherapy started until the date of death caused by thymus tumor treated in this study , assessed up to 100 months.