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Hyperthermic intrathoracic chemotherapy (HITOC) offers an additional treatment option for malignant pleural tumors after surgical cytoreduction. Especially it is used to further improve local tumor control in thymic malignancies with pleural spread, who underwent multimodality therapy including surgical resection. A phase II clinical study was conducted to explore the efficacy and safety of surgery followed by HITOC (POD1: DOX, POD2: cisplatin) for thymic epithelial tumors with pleural spread or recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HITOC | Other | HITOC group contains all patients who undergo HIROC in this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HITOC | Procedure | Doxorubicin(dose: 25mg/m2) + Cisplatin(dose: 50mg/m2). |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative hospital stay | Postoperative hospital stay is the duration for every enrolled patient until the date of meeting the criteria of hospital discharge since the date of surgery. The criteria of hospital discharge were defined as with the volume of postoperative drainage < 200 ml/day, a normal chest X-ray, and good physical condition. | Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month |
| treatment-related adverse events and complications | Number and severity of adverse events that are related to the treatment of each patient. Postoperative treatment-related complications were assessed by the Clavien-Dindo Classification. Treatment-related adverse events as assessed by CTCAE v5.0. | Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month |
| EORTC QLQ-C30 score for overall quality of life | Overall quality of life is respectively evaluated at randomization and 1 month, 3 month, 6 month after surgery among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 Scale (EORTC QLQ-C30) (V3.0). The minimum value of EORTC QLQ-C30 score was 0， and the maximum was 100. Zero indicates the worst quality of life, while 100 represents the best quality of life. | Up to the end of follow-up since the date of randomization, up to 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scales scores for postoperative pain | the cumulative daily pain score at rest using VAS from postoperative 0 to 72 hours. The minimum value of the VAS score was 0，and the maximum was 10. Zero indicates the least painful, while 1 represents the worst. The smaller (larger) cumulative daily pain score represents the less (more) pain. | from 0 to 72 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianyong Ding, MD | Contact | 18616881268 | ding.jianyong@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40467556 | Derived | Wang S, Yang X, Jiang J, Liang F, Zheng Y, Ao Y, Gao J, Wang H, Tan L, Ding J. Cytoreductive surgery and hyperthermic intrathoracic chemotherapy in thymic epithelial tumors with pleural spread or recurrence: a prospective, single-arm, phase II study. Nat Commun. 2025 Jun 4;16(1):5175. doi: 10.1038/s41467-025-60386-0. | |
| 38410567 | Derived |
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| ID | Term |
|---|---|
| C536905 | Thymic epithelial tumor |
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A Prospective single-arm Study
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| Volume of postoperative drainage | The volume of postoperative drainage of the patient was the sum of his daily drainage volume after the surgery. The types of drainage equipment include the thorax close drainage equipment and the unidirectional negative-pressure drainage ball. | Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days |
| Progression-free survival (PFS) | the duration from the date of S-HITOC to the date of the first progression. Disease progression is defined as locoregional (anterior mediastinal area, lung, pericardiac metastasis or pleural progression) or metastatic (supraclavicular lymph nodes or distant organs). | Through study completion, an average of 5 year |
| Overall survival (OS) | the duration from the date of S-HITOC to the date of the death. | Through study completion, an average of 5 year |
| Yang X, Wang S, Jiang J, Lin M, Gao J, Ding J, Tan L. Cytoreductive surgery combined with hyperthermic intrathoracic chemotherapy for the treatment of thymic epithelial malignancies with pleural spread or recurrence (CHOICE): a study protocol for a prospective, open, single-arm study. J Thorac Dis. 2024 Jan 30;16(1):760-767. doi: 10.21037/jtd-23-759. Epub 2023 Dec 25. |