Clinical trial NCT05446935: Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence
Official title: Cytoreductive Surgery and Hyperthermic Intrathoracic Chemotherapy for the Treatment of Thymic Epithelial Malignancies With Pleural Spread or Recurrence (CHOICE): a Prospective, Open, Single-arm Study Choice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thymic Epithelial Tumor
Keywords: Hyperthermic Intrathoracic Chemotherapy
Thymic Epithelial Malignancies
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 37
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Prospective single-arm Study
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Puncture biopsy, thoracoscopic/mediastinal biopsy, or surgery to confirm pathologically thymic epithelial tumor (TETs)
2. Imaging examination shows TETs with pleural spread or recurrence, and the mediastinal MDT team considers HITOC suitable.
3. Patients with ≥16 and ≤80 years old.
4. ASA I-II.
5. The patients should have no functional disorders in the main organs.
6. There was no history of other malignant carcinomas.
7. 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.
8. Not allergic to cisplatin or doxorubicin.
9. The patients should be able to understand our research and sign the informed consent.

Exclusion Criteria:

1. Imaging or pathological examination shows TETs without pleural spread or recurrence, or with pericardial dissemination or extrathoracic metastasis.
2. Patients with lymphoid system, neurogenic or reproductive system carcinoma.
3. Patients who have been receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
4. Patients with myasthenia gravis in unstable or acute exacerbation stage.
5. 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.
6. 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.
7. Female who is positive for a serum pregnancy test or during lactation period.
8. The patients have a history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation.
9. The patients have a history of peripheral nerve system disorders, obvious mental disorders, or central nerve system disorders.
10. The patients attend other clinical trials.

Primary outcomes:
measure: Postoperative hospital stay
timeFrame: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
measure: 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
measure: 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.
Secondary outcomes:
measure: Visual Analog Scales scores for postoperative pain
timeFrame: from 0 to 72 hours after surgery
measure: Volume of postoperative drainage
timeFrame: Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days
measure: Progression-free survival (PFS)
timeFrame: Through study completion, an average of 5 year
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 5 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
References: