The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor

NCT06311968 | Recruiting Phase 2 DMC

• 1 other identifier: SPHIC-TR-THLC2023-07
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thymus Epithelial Tumor; Proton Radiotherapy; Radiation Toxicity

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Overall survival rate

  From date of radiotherapy started until the date of death from any cause, assessed up to 100 months.

• Cause-specific survival rate

  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.

Study Arms (1)

Study arm

EXPERIMENTAL

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.

Radiation: Proton radiotherapy; Other: combined platinum based chemotherapy

Interventions

Proton radiotherapy RADIATION

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.

Study arm

combined platinum based chemotherapy OTHER

combined platinum based chemotherapy

Study arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jian Chen: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201513, China

RECRUITING

MeSH Terms

Conditions

Thymic epithelial tumor; Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jingfang Mao, PHD

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Li

CONTACT

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

Kun Liu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 15, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

CN (1)