- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05446935
Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence (CHOICE)
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jianyong Ding, MD
- Phone Number: 18616881268
- Email: ding.jianyong@zs-hospital.sh.cn
Study Locations
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Shanghai, China, 200032
- Recruiting
- Shanghai Zhongshan Hospital
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Contact:
- Jianyong Ding, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
- The patients should be able to understand our research and sign the informed consent.
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.
- 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.
- The patients have a history of peripheral nerve system disorders, obvious mental disorders, or central nerve system disorders.
- The patients attend other clinical trials.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: HITOC
HITOC group contains all patients who undergo HIROC in this study.
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Doxorubicin(dose: 25mg/m2) + Cisplatin(dose: 50mg/m2).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative hospital stay
Time Frame: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
|
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
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treatment-related adverse events and complications
Time Frame: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
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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.
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Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
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EORTC QLQ-C30 score for overall quality of life
Time Frame: Up to the end of follow-up since the date of randomization, up to 6 months.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume of postoperative drainage
Time Frame: Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days
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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.
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Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days
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Visual Analog Scales scores for postoperative pain
Time Frame: from 0 to 72 hours after surgery
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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.
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from 0 to 72 hours after surgery
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Progression-free survival (PFS)
Time Frame: Through study completion, an average of 5 year
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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).
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Through study completion, an average of 5 year
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Overall survival (OS)
Time Frame: Through study completion, an average of 5 year
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the duration from the date of S-HITOC to the date of the death.
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Through study completion, an average of 5 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2021-703R
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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