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NOT YET RECRUITING
NCT07383142
NA

Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence (CHOICE-2)

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

Hyperthermic intrathoracic chemotherapy (HITOC) offers a strategy to eliminate microscopic residual disease after surgical resection. Especially it is investigated to improve long-term survival in thymic epithelial tumors with pleural dissemination or recurrence. A prospective, multicenter, randomized phase III clinical trial (CHOICE-2) is conducted to compare the efficacy and safety of surgery combined with HITOC versus surgery alone. The HITOC regimen involves intrathoracic perfusion with doxorubicin on postoperative day 1 and cisplatin on postoperative day 2.

Official title: Surgery Combined With Hyperthermic Intrathoracic Chemotherapy Versus Surgery Alone for Pleural Dissemination or Pleural Recurrence of Thymic Epithelial Tumors: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2026-02-01

Completion Date

2032-02-01

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

PROCEDURE

Surgery alone

Patients undergo lung-preserving cytoreductive surgery, including pleurectomy/decortication (P/D) or extended pleurectomy/decortication (eP/D), via video-assisted thoracoscopic surgery (VATS) or thoracotomy. The goal is to achieve macroscopic complete resection of all visible pleural nodules and involved structures (e.g., pericardium, diaphragm). Extrapleural pneumonectomy (EPP) is excluded from the surgical strategy.

PROCEDURE

Surgery+HITOC

Patients undergo the same cytoreductive surgery (P/D or eP/D) as the control group. Following surgery, patients receive hyperthermic intrathoracic chemotherapy (HITOC) using a hyperthermic perfusion system heated to 43°C. The regimen consists of intrathoracic perfusion with doxorubicin (25 mg/m²) on postoperative day 1 (POD 1), followed by intrathoracic perfusion with cisplatin (50 mg/m²) on postoperative day 2 (POD 2).

Locations (1)

Shanghai Zhongshan Hospital

Shanghai, China