Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence

NCT05446935 | Unknown

• 1 other identifier: B2021-703R
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Thymic Epithelial Tumor

Keywords

Hyperthermic Intrathoracic Chemotherapy; Thymic Epithelial Malignancies

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to the end of follow-up since the date of randomization, up to 6 months.

Secondary Outcomes (4)

• Visual Analog Scales scores for postoperative pain

  from 0 to 72 hours after surgery

• Volume of postoperative drainage

  Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days

• Progression-free survival (PFS)

  Through study completion, an average of 5 year

• Overall survival (OS)

  Through study completion, an average of 5 year

Study Arms (1)

HITOC

OTHER

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

Procedure: HITOC

Interventions

HITOC PROCEDURE

Doxorubicin(dose: 25mg/m2) + Cisplatin(dose: 50mg/m2).

HITOC

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, 200032, China

RECRUITING

Related Publications (2)

• Wang S, Yang X, Jiang J, Liang F, Zheng Y, Ao Y, Gao J, Wang H, Tan L, Ding J. Cytoreductive surgery and hyperthermic intrathoracic chemotherapy in thymic epithelial tumors with pleural spread or recurrence: a prospective, single-arm, phase II study. Nat Commun. 2025 Jun 4;16(1):5175. doi: 10.1038/s41467-025-60386-0.

  PMID: 40467556 DERIVED

• Yang X, Wang S, Jiang J, Lin M, Gao J, Ding J, Tan L. Cytoreductive surgery combined with hyperthermic intrathoracic chemotherapy for the treatment of thymic epithelial malignancies with pleural spread or recurrence (CHOICE): a study protocol for a prospective, open, single-arm study. J Thorac Dis. 2024 Jan 30;16(1):760-767. doi: 10.21037/jtd-23-759. Epub 2023 Dec 25.

  PMID: 38410567 DERIVED

MeSH Terms

Conditions

Thymic epithelial tumor

Central Study Contacts

Jianyong Ding, MD

CONTACT

18616881268; ding.jianyong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Prospective single-arm Study

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 7, 2022
• Study Start: October 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

CN (1)