Stage IVA ThymomaPhase 1/2NCT04371458
Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies
A Phase 1/2 study testing Intraoperative providone-iodine lavage in people with Stage IVA Thymoma, run by Yale University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IVA Thymoma
- What is being tested?
- Intraoperative providone-iodine lavage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jul 2030
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
Official title: The Study of Extended Thymectomy and Pleural Reductive Surgery (PRS) With Povidone-iodine Pleural Lavage in Patients With Stage IVA Thymic Malignancies
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
Read the 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.
- Conditions
- Stage IVA Thymoma
- Being tested
- Intraoperative providone-iodine lavage
- Keywords
- Intra-Pleural Providone-Iodine
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative providone-iodine lavageDrug
Intraoperative providone-iodine lavage during resection
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative providone-iodine lavage | Experimental | Intraoperative providone-iodine lavage during resection Receives: Drug: Intraoperative providone-iodine lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival as compared to that of matched patients in a prospectively enrolled international database of thymic malignancies (ITMIG)
Measured: 5 years
Secondary outcomes (3)
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.
Measured: 5 years
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.
Measured: 5 years
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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study startJul 2020 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2030 (estimated)
Why it stopped: PI is not moving forward with study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IVA ThymomaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intraoperative providone-iodine lavage during resection
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371458
- Sponsor's protocol ID
- 2000026157
- Status last verified
- Jul 2022
- First submitted
- 28 Apr 2020
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Extended Thymectomy and Pleural Reductive Surgery (PRS) With Povidone-iodine Pleural Lavage in Patients With Stage IVA Thymic Malignancies
- ClinicalTrials.gov ID
- NCT04371458
- Acronym / sponsor ID
- 2000026157
- Conditions
- Stage IVA Thymoma
- Keywords
- Intra-Pleural Providone-Iodine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is not moving forward with study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intraoperative providone-iodine lavage during resection
| Arm | Type | Receives |
|---|---|---|
| Intraoperative providone-iodine lavage | Experimental | Drug: Intraoperative providone-iodine lavageIntraoperative providone-iodine lavage during resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative providone-iodine lavageIntraoperative providone-iodine lavage during resection | Drug | Intraoperative providone-iodine lavage |
Primary outcome
Progression free survival
Time frame: 5 years
Progression free survival as compared to that of matched patients in a prospectively enrolled international database of thymic malignancies (ITMIG)
3 secondary outcomes
Pleural recurrence
Time frame: 5 years
Overall survival
Time frame: 5 years
Patient and disease characteristics
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Stage IVA Thymoma
Active, not recruitingPhase 2
Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma
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RecruitingPhase 1
Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer
Stage III Thymoma AJCC v8, Stage IIIA Thymoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intraoperative providone-iodine lavage in people with Stage IVA Thymoma, run by Yale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.