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Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence (CHOICE)

Primary Purpose

Thymic Epithelial Tumor

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HITOC
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymic Epithelial Tumor focused on measuring Hyperthermic Intrathoracic Chemotherapy, Thymic Epithelial Malignancies

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HITOC

Arm Description

HITOC group contains all patients who undergo HIROC in this study.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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).
Overall survival (OS)
the duration from the date of S-HITOC to the date of the death.

Full Information

First Posted
June 28, 2022
Last Updated
September 15, 2022
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05446935
Brief Title
Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence
Acronym
CHOICE
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymic Epithelial Tumor
Keywords
Hyperthermic Intrathoracic Chemotherapy, Thymic Epithelial Malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A Prospective single-arm Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HITOC
Arm Type
Other
Arm Description
HITOC group contains all patients who undergo HIROC in this study.
Intervention Type
Procedure
Intervention Name(s)
HITOC
Intervention Description
Doxorubicin(dose: 25mg/m2) + Cisplatin(dose: 50mg/m2).
Primary Outcome Measure Information:
Title
Postoperative hospital stay
Description
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
Title
treatment-related adverse events and complications
Description
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
Title
EORTC QLQ-C30 score for overall quality of life
Description
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.
Secondary Outcome Measure Information:
Title
Visual Analog Scales scores for postoperative pain
Description
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
Title
Volume of postoperative drainage
Description
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
Title
Progression-free survival (PFS)
Description
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
Title
Overall survival (OS)
Description
the duration from the date of S-HITOC to the date of the death.
Time Frame
Through study completion, an average of 5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianyong Ding, MD
Phone
18616881268
Email
ding.jianyong@zs-hospital.sh.cn
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyong Ding, MD

12. IPD Sharing Statement

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Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence

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