Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence (NCT05446935) | Clinical Trial Compass
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Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence
China37 participantsStarted 2022-10-01
Plain-language summary
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.
Who can participate
Age range16 Years – 80 Years
SexALL
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Inclusion criteria
✓. Puncture biopsy, thoracoscopic/mediastinal biopsy, or surgery to confirm pathologically thymic epithelial tumor (TETs)
✓. Imaging examination shows TETs with pleural spread or recurrence, and the mediastinal MDT team considers HITOC suitable.
✓. Patients with ≥16 and ≤80 years old.
✓. ASA I-II.
✓. The patients should have no functional disorders in the main organs.
✓. There was no history of other malignant carcinomas.
✓. The duration from the last chemotherapy was \>4 weeks, the duration from the last radiotherapy was \>6 weeks, and the duration from the last immunotherapy was \>6 weeks.
✓. Not allergic to cisplatin or doxorubicin.
Exclusion criteria
✕. Imaging or pathological examination shows TETs without pleural spread or recurrence, or with pericardial dissemination or extrathoracic metastasis.
✕. Patients with lymphoid system, neurogenic or reproductive system carcinoma.
✕. Patients who have been receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
✕. Patients with myasthenia gravis in unstable or acute exacerbation stage.
What they're measuring
1
Postoperative hospital stay
Timeframe: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
2
treatment-related adverse events and complications
Timeframe: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
3
EORTC QLQ-C30 score for overall quality of life
Timeframe: Up to the end of follow-up since the date of randomization, up to 6 months.
. The patients have been proven history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control.
✕. The patients have the severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under-treatment of thrombolysis or anticoagulant therapy.
✕. Female who is positive for a serum pregnancy test or during lactation period.
✕. The patients have a history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation.