Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
NCT Number: NCT07691619
This is a prospective, open-label, single-arm Phase II study designed to evaluate the safety of postoperative hypofractionated radiotherapy in patients with Stage II/III thymic epithelial tumors after complete resection. After a screening period of up to 28 days, eligible patients will receive adjuvant hypofractionated radiotherapy to a total dose of 40 Gy in 15 fractions, delivered once daily at 2.67 Gy per fraction, 5 days per week over 3 weeks. The study will primarily assess treatment-related safety and tolerability, with preliminary evaluation of efficacy, economic burden, and quality of life.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The investigational treatment consists of postoperative hypofractionated radiotherapy delivered at a total dose of 40 Gy in 15 fractions (2.67 Gy per fraction), administered 5 days per week.
Time frame: Up to 3 months
Percentage of participants who experience treatment-related Grade 2 or higher acute adverse events from the start of radiotherapy to 3 months after completion of radiotherapy, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).
Time frame: Up to 3 years
Time from the start of radiotherapy to the first documented disease recurrence, distant metastasis, or death from any cause, whichever occurs first.
Time frame: Up to 3 years
Time from the start of radiotherapy to death from any cause.
Time frame: Up to 3 years
ercentage of participants who develop locoregional recurrence during follow-up. Locoregional recurrence includes recurrence in the tumor bed, mediastinum, pleura, or regional lymph nodes, as assessed by imaging, pathology, or clinical evaluation.
Time frame: Up to 3 years
Percentage of participants who develop distant metastasis during follow-up, as assessed by imaging, pathology, or clinical evaluation.
Time frame: Up to 3 years
Percentage of participants who die from any cause during follow-up.
Time frame: From 6 months after completion of radiotherapy to 3 years
Percentage of participants who experience treatment-related late adverse events occurring 6 months or later after completion of radiotherapy, including pulmonary, cardiac, esophageal, or other late adverse events, assessed according to NCI-CTCAE v5.0.
Time frame: Up to 3 years
Total economic cost per participant during the study period, including direct medical costs, non-medical costs, and indirect costs. Direct medical costs include radiotherapy costs, radiotherapy-related symptomatic treatment costs, and costs for the management of toxic and adverse reactions. Non-medical and indirect costs include transportation costs, accommodation costs, and lost work or companion time costs. Costs will be calculated in Chinese Yuan.
Time frame: Up to 3 years
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The global health status/quality of life score will be recorded at baseline and predefined follow-up visits. Scores range from 0 to 100, with higher scores indicating better global health status/quality of life.
Time frame: Up to 3 years
Swallowing function will be assessed using the Standardized Swallowing Assessment (SSA). The total SSA score will be recorded at baseline and predefined follow-up visits, with higher scores indicating worse swallowing function.
Time frame: From baseline to up to 3 years after radiotherapy
Odds ratios for cardiac-related disease occurrence per 1-Gy increase in predefined cardiac and coronary artery dose parameters will be estimated using logistic regression. Predefined dose parameters will include mean heart dose and coronary artery substructure dose parameters, measured in Gray (Gy) from the radiotherapy treatment plan. Cardiac-related disease occurrence will be defined as the occurrence of clinically diagnosed cardiac disease or cardiac adverse events during follow-up, assessed by clinical cardiac evaluation and NCI-CTCAE v5.0. Cardiac-related diseases or adverse events may include coronary artery disease, myocardial ischemia or infarction, arrhythmia, heart failure, pericardial disease, or other clinically diagnosed cardiac events.
Contact information is provided by the study sponsor or research team.
Tianjin Medical University Cancer Institute and Hospital
Other
A Prospective, Single-Arm Phase II Clinical Study of Hypofractionated Adjuvant Radiotherapy After Complete Resection for Stage II/III Thymic Epithelial Tumors
Acronym: TET-HFRT40
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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