Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies

NCT04371458 | Withdrawn Phase 1 DMC

• 1 other identifier: 2000026157
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Stage IVA Thymoma

Keywords

Intra-Pleural Providone-Iodine

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression free survival as compared to that of matched patients in a prospectively enrolled international database of thymic malignancies (ITMIG)

  5 years

Secondary Outcomes (3)

• Pleural recurrence

  5 years

• Overall survival

  5 years

• Patient and disease characteristics

  5 years

Study Arms (1)

Intraoperative providone-iodine lavage

EXPERIMENTAL

Intraoperative providone-iodine lavage during resection

Drug: Intraoperative providone-iodine lavage

Interventions

Intraoperative providone-iodine lavage DRUG

Intraoperative providone-iodine lavage during resection

Intraoperative providone-iodine lavage

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

MeSH Terms

Conditions

Thymoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intraoperative providone-iodine lavage during resection

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 1, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share