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Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT06311955•Jian Chen

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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 β-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.

Locations (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

July 1, 2025

Primary Completion Date

February 28, 2028

Completion Date

February 28, 2029

Last Updated

June 13, 2025

Enrollment

ESTIMATED participants

Conditions

Thymic Epithelial TumorRadiotherapy Side EffectCarbon Ion RadiotherayHeavy Ion Radiotherapy

Interventions

Carbon ion radiotherapy

RADIATION

combined with platinum-based regimen

OTHER

Contacts

Jing Li

CONTACT

86-21-38296678 jing.li@sphic.org.cn

Kun Liu

CONTACT

86-21-38296678 kun.liu@sphic.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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