Clinical trial · Interventional
Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies
The Study of Extended Thymectomy and Pleural Reductive Surgery (PRS) With Povidone-iodine Pleural Lavage in Patients With Stage IVA Thymic Malignancies
NCT04371458CI-TRIAL-00059841withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI is not moving forward with study
Summary
Brief summary (as posted)
To evaluate whether intraoperative pleural lavage with providone-iodine following complete resection and pleural reductive surgery for stage IVA thymoma reduces recurrent rates compared to surgery without providone-iodine lavage
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IVA Thymoma | Thymoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative providone-iodine lavage | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative providone-iodine lavage
- description
- Intraoperative providone-iodine lavage during resection
- interventionNames
- Drug: Intraoperative providone-iodine lavage
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 5 years
- description
- Progression free survival as compared to that of matched patients in a prospectively enrolled international database of thymic malignancies (ITMIG)
Secondary outcomes (3)
- measure
- Pleural recurrence
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group - PS 0 or 1 * Patients with a histologic diagnosis of thymic epithelial tumor (thymoma WHO type A, AB, B1, B2, B3; or thymic carcinoma) who in the opinion of the attending thoracic surgeon can technically receive a macroscopic complete resection of pleural nodules. This histologic diagnosis can be obtained either preoperatively, or based on frozen section intra-operatively. * Signed informed consent form * Completely resectable burden of disease * No evidence of distant organ metastasis except resectable pulmonary parenchymal nodules and intrathoracic lymph node metastasis as evidenced by CT chest, physical examination, and any other indicated studies * Medically suitability for resection as determined by the operating surgeon * Women of childbearing potential (WOCBP) must have a negative urinary pregnancy test pre-operatively Exclusion Criteria: * Patients with active invasive cancers, other than thymoma, that requires treatment, except non-melanomatous skin cancer, superficial bladder cancer or cervical cancer and early stage prostate cancer. * If frozen section reveals a diagnosis other than thymoma or thymic carcinoma, the patient will be removed from protocol and the providone-iodine lavage will not be performed. * Hyperthyroidism or Radioisotope treatment for thyroid disease. * Radiographic evidence of disease beyond the primary site and pleural space * History of pulmonary resection more than lobectomy. (regardless of laterality) * Pregnant or lactating patients * Patients with iodine allergy * Patients who have severe liver disease including cirrhosis, grade III-IV elevations in liver function studies, or bilirubin in excess of 1.5 mg/decilitre * Pulmonary nodules or visceral nodules requiring pulmonary resection sacrificing more than half of ipsilateral lung parenchyma.
References
Publications (0)
Data not yet available
No reference posted for this study.