Malignant Pericardial EffusionPhase 3NCT00132613
Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
A Phase 3 study testing Observation alone after pericardial drainage and Pericardial instillation of bleomycin after drainage in people with Malignant Pericardial Effusion, run by Japan Clinical Oncology Group at 31 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Malignant Pericardial Effusion
- What is being tested?
- Observation alone after pericardial drainage and Pericardial instillation of bleomycin after drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 31 sitesJapan
- Study dates
- Aug 1999to Nov 2006
- Phase
- Phase 3
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathologically documented lung cancer
- Clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary that it be documented by cytology)
- Expected to live 6 weeks or longer
- Sufficient organ function
- Signed informed consent
Who cannot join
- Myocardial infarction or unstable angina within 3 months
- Constrictive pericarditis
- Active pneumonitis
- Severe infection or disseminated intravascular coagulation (DIC)
- Other severe co-morbidity which could not be relieved with pericardial drainage
- Chemotherapy-naive small cell lung cancer
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Japan31 sites
National Hospital Organization, Dohoku National Hospital
Asahikawa,Hanasaki,7-4048, Hokkaido, 070-8644
National Cancer Center Hospital
Chuo-ku,Tsukiji, 5-1-1, Tokyo, 104-0045
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, 500-8323
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino,Habikino,3-7-1, Osaka, 583-8588
Rinku General Medical Center
Izumisano,rinku-ohrai-kita,2-23, Osaka, 598-0048
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, 362-0806
Kobe City General Hospital
Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyōgo, 650-0046
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, 135-8550
Kumamoto Regional Medical Center Hospital
Kumamoto,Honjo,5-16-10, Kumamoto, 860-0811
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 309-1793
Hyogo College of Medicine
Nishinomiya,Mukogawa-cho,1-1, Hyōgo, 663-8501
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, 444-0011
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511
Graduate School of Medicine, Osaka City University
Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, 545-0051
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, 373-8550
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai,Nagasone,1180, Osaka, 591-8555
National Hospital Organization Hokkaido Cancer Center
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, 003-0804
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574
National Nishigunma Hospital
Shibukawa,Kanai,2854, Gunma, 377-8511
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, 162-8655
National Hospital Organization Toneyama National Hospital
Toyonaka,Toneyama,5-1-1, Osaka, 560-8552
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, 990-2292
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815
Yokohama Mucipical Citizen's Hospital
Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, 240-8555
About this study
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Intra-pericardial Instillation of a Sclerosing Agent After Pericardial Drainage in Patients With Malignant Pericardial Effusion Associated With Lung Cancer (JCOG9811)
The purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion.
Read the detailed description
Malignant pericardial effusions (MPEs), which are commonly associated with cardiac tamponade, make oncologic emergencies requiring prompt drainage. In lung cancer patients, MPE is one of the most unpleasant terminal events. Drainage usually results in prompt palliation of symptoms, but recurrent effusions often occur. Sclerosis with pericardial instillation of various agents is reported to prevent the recurrence, and bleomycin is the most commonly used drug, with fewer toxicities compared with others. There is, however, no prospective trial of pericardial sclerosis as compared with drainage alone for MPEs, and it is far from clear whether sclerosis really benefits these patients in terminal stages.
Comparison: Intra-pericardial instillation of bleomycin after pericardial drainage versus drainage alone for MPEs caused by lung cancer.
- Conditions
- Malignant Pericardial Effusion
- Being tested
- Observation alone after pericardial drainage, Pericardial instillation of bleomycin after drainage
- Keywords
- pulmonary neoplasm, malignant pericardial effusion, pericardial drainage, randomized trial, bleomycin, intrapericardial instillation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation alone after pericardial drainageProcedure or surgery
Pericardial instillation of bleomycin after drainageDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Procedure/Surgery: Observation alone after pericardial drainage Receives: Procedure: Observation alone after pericardial drainage |
| 2 | Experimental | Drug: Pericardial instillation of bleomycin after drainage Receives: Drug: Pericardial instillation of bleomycin after drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without pericardial effusion at 2 months
Secondary outcomes (6)
Successful extubation of pericardial drainage tube
time to extubation
survival without pericardial effusion at 1, 2, 4, 6, 12 months
symptom palliation
complication
long-term (> 6 months) effect on cardiac function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startAug 1999
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pericardial EffusionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Clinical Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Investigators
- Tomohide Tamura, MD, Study chair, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132613
- Sponsor's protocol ID
- JCOG9811
- Other IDs
- C000000030
- Status last verified
- Sep 2016
- First submitted
- 19 Aug 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Efficacy of Intra-pericardial Instillation of a Sclerosing Agent After Pericardial Drainage in Patients With Malignant Pericardial Effusion Associated With Lung Cancer (JCOG9811)
- ClinicalTrials.gov ID
- NCT00132613
- Acronym / sponsor ID
- JCOG9811
- Conditions
- Malignant Pericardial Effusion
- Keywords
- pulmonary neoplasm, malignant pericardial effusion, pericardial drainage, randomized trial, bleomycin, intrapericardial instillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Japan Clinical Oncology GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Aug 1999
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Aug 2005 (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 purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion.
Detailed description
Malignant pericardial effusions (MPEs), which are commonly associated with cardiac tamponade, make oncologic emergencies requiring prompt drainage. In lung cancer patients, MPE is one of the most unpleasant terminal events. Drainage usually results in prompt palliation of symptoms, but recurrent effusions often occur. Sclerosis with pericardial instillation of various agents is reported to prevent the recurrence, and bleomycin is the most commonly used drug, with fewer toxicities compared with others. There is, however, no prospective trial of pericardial sclerosis as compared with drainage alone for MPEs, and it is far from clear whether sclerosis really benefits these patients in terminal stages.
Comparison: Intra-pericardial instillation of bleomycin after pericardial drainage versus drainage alone for MPEs caused by lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Observation alone after pericardial drainageProcedure/Surgery: Observation alone after pericardial drainage |
| 2 | Experimental | Drug: Pericardial instillation of bleomycin after drainageDrug: Pericardial instillation of bleomycin after drainage |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically documented lung cancer
- Clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary that it be documented by cytology)
- Expected to live 6 weeks or longer
- Sufficient organ function
- Signed informed consent
Key exclusion criteria (6 listed)
- Myocardial infarction or unstable angina within 3 months
- Constrictive pericarditis
- Active pneumonitis
- Severe infection or disseminated intravascular coagulation (DIC)
- Other severe co-morbidity which could not be relieved with pericardial drainage
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 |
|---|---|---|
| Observation alone after pericardial drainage | Procedure or surgery | 1 |
| Pericardial instillation of bleomycin after drainage | Drug | 2 |
Primary outcome
Survival without pericardial effusion at 2 months
6 secondary outcomes
Successful extubation of pericardial drainage tube
time to extubation
survival without pericardial effusion at 1, 2, 4, 6, 12 months
symptom palliation
complication
long-term (> 6 months) effect on cardiac function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Related InfoLink provided by the sponsor.
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.
Tomohide Tamura, MD study chair
National Cancer Center Hospital
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Observation alone after pericardial drainage and Pericardial instillation of bleomycin after drainage in people with Malignant Pericardial Effusion, run by Japan Clinical Oncology Group at 31 sites in Japan.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival without pericardial effusion at 2 months. 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 22 Sep 2016.