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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Doxorubicin(dose: 25mg/m2) + Cisplatin(dose: 50mg/m2).
Shanghai Zhongshan Hospital
Shanghai, China
RECRUITINGPostoperative 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to the end of follow-up since the date of randomization, up to 6 months.
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.
Time frame: from 0 to 72 hours after surgery
Volume of postoperative drainage
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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.
Time frame: 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).
Time frame: 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.
Time frame: Through study completion, an average of 5 year