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

Primary Purpose

Stage IVA Thymoma

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Intraoperative providone-iodine lavage

About this trial

This is an interventional treatment trial for Stage IVA Thymoma focused on measuring Intra-Pleural Providone-Iodine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative providone-iodine lavage

Arm Description

Intraoperative providone-iodine lavage during resection

Outcomes

Primary Outcome Measures

Progression free survival

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

Secondary Outcome Measures

Pleural recurrence

Pleural recurrence will be assessed with CT scans of the chest every 6 months starting 6 months after the index operation and continuing for 3 years. After 3 years, if no recurrence has been identified yet, patients will get CT scans of the chest on an annual basis.

Overall survival

Overall survival will be assessed by regular patient evaluations, which will correspond with the CT scans of the chest. If a patient expires, date and cause of death will be recorded. Causes related to thymic malignancy will be differentiated from other causes of mortality to arrive at disease-specific survival and all-cause overall survival.

Patient and disease characteristics

Identification of patient and disease characteristics associated with improved responses to providone-iodine lavage. Variables examined will include demographic data such as age, sex and comorbidities. Additional data evaluated will include specific aspects of the primary thymic tumor such as burden of thoracic disease (confined to mediastinum, extension into ipsilateral pleura, burden of disease in pleura), and pathology characteristics (WHO Type, level of differentiation).

Full Information

NCT ID

NCT04371458

First Posted

April 28, 2020

Last Updated

July 19, 2022

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT04371458

Brief Title

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

Official Title

The Study of Extended Thymectomy and Pleural Reductive Surgery (PRS) With Povidone-iodine Pleural Lavage in Patients With Stage IVA Thymic Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Withdrawn

Why Stopped

PI is not moving forward with study

Study Start Date

July 2020 (Anticipated)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

Following the surgical portion of the procedure, assuming frozen section confirms the suspected diagnosis, pleural lavage using 10% povidone-iodine (warmed to normothermic 37°C) will begin. The 10% povidone-iodine is mixed with sterile water with a dilution of 1/10. A total of 6-14 liters of solution will be prepared in advance of the procedure, pending the size of the patient's chest cavity. The warmed PVP-I will be instilled into the chest cavity to a volume that fills involved thoracic cavity or cavities. Once filled, the solution will be allowed to dwell for 15 minutes. At the conclusion of the 15 minutes, the PVP-I solution will be suctioned out of the chest. This process will be repeated for a total of three dwell sessions. At the conclusion of the PVP-I lavage, chest tubes should be placed in the chest cavity to re-expand the lung adequately. Chest tube management will be at the discretion of the individual thoracic surgeons, including suction vs water seal and plan for removal. An honest attempt to maintain the management according to the study protocol will be made. However, if it deemed inappropriate for that patient due to clinical signs, symptoms, or anticipated problems, the surgical team can make whatever changes are deemed necessary. The reason for the deviation must be documented. This patient's data will continue to be collected and analyzed on an intent-to-treat basis for the primary, secondary and tertiary endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage IVA Thymoma

Keywords

Intra-Pleural Providone-Iodine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Intraoperative providone-iodine lavage during resection

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intraoperative providone-iodine lavage

Arm Type

Experimental

Arm Description

Intraoperative providone-iodine lavage during resection

Intervention Type

Drug

Intervention Name(s)

Intraoperative providone-iodine lavage

Intervention Description

Intraoperative providone-iodine lavage during resection

Primary Outcome Measure Information:

Title

Progression free survival

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Pleural recurrence

Description

Time Frame

5 years

Title

Overall survival

Description

Time Frame

5 years

Title

Patient and disease characteristics

Description

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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