Advanced CancerPhase 2NCT00761618
Intrapleural Catheter Daily Versus Three Times a Week Drainage
A Phase 2 study testing Intrapleural catheter (IPC) drained, IPC Placement and Chest X-Ray in people with Advanced Cancer and Pleural Effusion, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if draining the IPC every day is better at than draining it 3 times a week. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Pleural Effusion
- What is being tested?
- Intrapleural catheter (IPC) drained, IPC Placement and Chest X-Ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2008to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients with symptomatic pleural effusion requiring placement of an IPC.
- Signed informed consent prior to any study related procedures.
- Subject must be age 18 years or over.
Who cannot join
- Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks incompletely healed surgical incision before randomization.
- Evidence of empyema or history of empyema of the affected hemithorax
- Non-correctable bleeding diathesis
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Principal Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- Participation in any clinical trial that prevents randomization of the subject to either strategy.
- Clinical evidence of skin infection at the potential site of IPC placement.
- Current or prior IPC placement, or any intervention to manage recurrent malignant pleural effusion on the contralateral hemithorax (excluding thoracentesis).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies
The goal of this clinical research study is to learn if draining the IPC every day is better at than draining it 3 times a week.
Read the detailed description
An IPC is a silicone (rubberlike) tube that is inserted into the chest cavity to drain excess fluid that is in your chest. At MD Anderson, patients are told to drain their IPC every day. At other institutions, patients are told to drain their IPC less often.
Before IPC Placement:
Before you can have the IPC inserted, the following tests and procedures will be performed to help the doctor decide if you need to have an IPC inserted:
- You will perform a 6 minute walk test to learn your check your breathing ability and fatigue level. To perform the walk test, you will be asked to walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time if necessary.
- After signing this consent, you will fill out 2 questionnaires asking questions about how you feel and any symptoms you may have. These questionnaires will take about 20-30 minutes to complete.
IPC placement:
You will have an IPC placed to drain the fluid in your chest cavity. You will be given a separate consent for to sign for this procedure and your doctor will give you detailed instructions regarding the procedure itself.
Study Groups:
A chest x-ray will be performed right after the IPC placement. You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups, after your chest x-ray or the following day when you return to clinic for follow up. Group 1 will have their IPC drained every day, and Group 2 will have their IPC drained 3 times a week (Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday). You will be given detailed instructions on when and how to drain your catheter.
Follow-Up Visits:
Two (2) weeks after you receive the IPC, you will return to the clinic for a follow-up visit so the doctor can check your IPC for possible leaking, infection, and see how much pleural fluid has drained. After the follow-up visit at 2 weeks, you will come into the clinic every 4 weeks until your IPC is removed. During each follow-up visit the following tests and procedures will be performed to see how your condition has changed:
- You will have a chest x-ray to see if the amount of pleural fluid has decreased and to see if your lung has re-expanded.
- You will perform the 6 minute walk test.
- You will complete the same 2 questionnaires.
- The IPC will be drained.
After the IPC is removed, at 3 and 6 months, you will have follow-up visits at M. D. Anderson or at your local doctor's office. At these visits you will have chest x-rays to see if the pleural fluid has come back or not.
The study personnel will contact you by phone, email or mail periodically during the study and at 3 months and 6 months after the IPC has been removed to check on your status. The phone calls, email, or mail follow-up will take about 5-10 minutes to complete. You will be asked how you are doing and if you have any questions or concerns that you may want to discuss with the your doctor. You will also be asked if you have had a chest x-ray since being off study. If you have had an x-ray, you will be asked to share the results with the study doctor.
This is an investigational study.
Up to 250 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancer, Pleural Effusion
- Being tested
- Intrapleural catheter (IPC) drained, IPC Placement, Chest X-Ray
- Keywords
- Intrapleural catheter, IPC, Pleurodesis, PD, Pleural effusion, Fluid in the chest cavity, Recurrent malignant pleural effusion, MPE, Pleural inflammatory response
- Medical subject headings
- Pleural Effusion, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapleural catheter (IPC) drainedProcedure or surgery
IPC drained daily (Group 1) or 3 times per week (Group 2)
IPC PlacementProcedure or surgery
Also called Indwelling Pleural Catheter
IPC placed in chest cavity to drain excess fluid
Chest X-RayRadiation
Chest X-Rays at 3 and 6 month follow up visits
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Daily | Experimental | Intrapleural Catheters (IPC) drained every day Receives: Procedure: Intrapleural catheter (IPC) drained; Procedure: IPC Placement; Radiation: Chest X-Ray |
| Arm 2 - 3 Times a Week | Experimental | IPC drained 3 times a week Receives: Procedure: Intrapleural catheter (IPC) drained; Procedure: IPC Placement; Radiation: Chest X-Ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Pleurodesis (TTP)
Time to pleurodesis (TTP), defined as the time from catheter insertion to catheter removal.
Measured: 2 weeks after intrapleural catheter placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study start22 Aug 2008
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- C. R. Bard
- Responsible party
- Sponsor
- Investigators
- Carlos A. Jimenez, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761618
- Sponsor's protocol ID
- 2007-0808
- Other IDs
- NCI-2012-01673
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2008
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies
- ClinicalTrials.gov ID
- NCT00761618
- Acronym / sponsor ID
- 2007-0808
- Conditions
- Advanced Cancer, Pleural Effusion
- Keywords
- Intrapleural catheter, IPC, Pleurodesis, PD, Pleural effusion, Fluid in the chest cavity, Recurrent malignant pleural effusion, MPE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 257 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- C. R. Bard
- Study start
- 22 Aug 2008 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 29 Sep 2008 (estimated)
- 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.
The goal of this clinical research study is to learn if draining the IPC every day is better at than draining it 3 times a week.
Detailed description
An IPC is a silicone (rubberlike) tube that is inserted into the chest cavity to drain excess fluid that is in your chest. At MD Anderson, patients are told to drain their IPC every day. At other institutions, patients are told to drain their IPC less often.
Before IPC Placement:
Before you can have the IPC inserted, the following tests and procedures will be performed to help the doctor decide if you need to have an IPC inserted:
- You will perform a 6 minute walk test to learn your check your breathing ability and fatigue level. To perform the walk test, you will be asked to walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time if necessary.
- After signing this consent, you will fill out 2 questionnaires asking questions about how you feel and any symptoms you may have. These questionnaires will take about 20-30 minutes to complete.
IPC placement:
You will have an IPC placed to drain the fluid in your chest cavity. You will be given a separate consent for to sign for this procedure and your doctor will give you detailed instructions regarding the procedure itself.
Study Groups:
A chest x-ray will be performed right after the IPC placement. You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups, after your chest x-ray or the following day when you return to clinic for follow up. Group 1 will have their IPC drained every day, and Group 2 will have their IPC drained 3 times a week (Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday). You will be given detailed instructions on when and how to drain your catheter.
Follow-Up Visits:
Two (2) weeks after you receive the IPC, you will return to the clinic for a follow-up visit so the doctor can check your IPC for possible leaking, infection, and see how much pleural fluid has drained. After the follow-up visit at 2 weeks, you will come into the clinic every 4 weeks until your IPC is removed. During each follow-up visit the following tests and procedures will be performed to see how your condition has changed:
- You will have a chest x-ray to see if the amount of pleural fluid has decreased and to see if your lung has re-expanded.
- You will perform the 6 minute walk test.
- You will complete the same 2 questionnaires.
- The IPC will be drained.
After the IPC is removed, at 3 and 6 months, you will have follow-up visits at M. D. Anderson or at your local doctor's office. At these visits you will have chest x-rays to see if the pleural fluid has come back or not.
The study personnel will contact you by phone, email or mail periodically during the study and at 3 months and 6 months after the IPC has been removed to check on your status. The phone calls, email, or mail follow-up will take about 5-10 minutes to complete. You will be asked how you are doing and if you have any questions or concerns that you may want to discuss with the your doctor. You will also be asked if you have had a chest x-ray since being off study. If you have had an x-ray, you will be asked to share the results with the study doctor.
This is an investigational study.
Up to 250 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Daily | Experimental | Procedure: Intrapleural catheter (IPC) drained, Procedure: IPC Placement, Radiation: Chest X-RayIntrapleural Catheters (IPC) drained every day |
| Arm 2 - 3 Times a Week | Experimental | Procedure: Intrapleural catheter (IPC) drained, Procedure: IPC Placement, Radiation: Chest X-RayIPC drained 3 times a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with symptomatic pleural effusion requiring placement of an IPC.
- Signed informed consent prior to any study related procedures.
- Subject must be age 18 years or over.
Key exclusion criteria (8 listed)
- Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks incompletely healed surgical incision before randomization.
- Evidence of empyema or history of empyema of the affected hemithorax
- Non-correctable bleeding diathesis
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Principal Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
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 |
|---|---|---|
| Intrapleural catheter (IPC) drainedIPC drained daily (Group 1) or 3 times per week (Group 2) | Procedure or surgery | Arm 1 - Daily, Arm 2 - 3 Times a Week |
| IPC PlacementAlso: Indwelling Pleural CatheterIPC placed in chest cavity to drain excess fluid | Procedure or surgery | Arm 1 - Daily, Arm 2 - 3 Times a Week |
| Chest X-RayChest X-Rays at 3 and 6 month follow up visits | Radiation | Arm 1 - Daily, Arm 2 - 3 Times a Week |
Primary outcome
Time to Pleurodesis (TTP)
Time frame: 2 weeks after intrapleural catheter placement
Time to pleurodesis (TTP), defined as the time from catheter insertion to catheter removal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Carlos A. Jimenez, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intrapleural catheter (IPC) drained, IPC Placement and Chest X-Ray in people with Advanced Cancer and Pleural Effusion, run by M.D. Anderson Cancer Center at 1 site in United States.
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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
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?
Time to Pleurodesis (TTP) (time frame: 2 weeks after intrapleural catheter placement). 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 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.