Malignant Pleural EffusionPhase 2NCT03987087
A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC
A Phase 2 study testing Radiation and Chemotherapy in people with Malignant Pleural Effusion and Nonsmall Cell Lung Cancer, Stage IV, run by Guizhou Medical University at 1 site in China.
Trial summary
This randomized phase II study compare survival outcomes and toxicity of malignant pleural effusion stage IV non small-cell lung cancer patients Intrapleural infusion chemotherapy in combination with concurrent thoracic radiation therapy (TRT) VS not combination with concurrent thoracic radiation therapy (TRT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Pleural Effusion, Nonsmall Cell Lung Cancer, Stage IV
- What is being tested?
- Radiation and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Dec 2021
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathological or cytological diagnosis, stage IV with malignant pleural effusion [UICC 2017 staging eighth edition] NSCLC patients;
- initial treatment (previously did not receive any treatment), it is recommended to complete the detection of driver genes (EGFR / ALK / ROS1) (tissue, blood);
- Age 18 to 80 years old, physical status score ECOG 0 to 2 or KPS ≥ 70 (see Annex 2); Metastatic lesions in the distant area: conscious when brain metastasis; the number of metastatic lesions in the lung does not affect lung function and may be treated with primary and/or partial metastases;
- no radiotherapy, EGFR-TKI and chemotherapy contraindications;
- primary tumor radiotherapy requires IMRT technology;
- Plan the design to give the primary tumor prescription dose (DTGTV) under the damage control threshold criteria;
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- The planned dose includes 100% GTV, 90% of the prescribed dose includes 98%~100% of PTV [planned target dose (DTPTV)]; normal lung (full lung volume minus GTV volume) V20 ≤ 32%, MLD≤20Gy;
- metastatic tumor radiotherapy is a three-dimensional radiotherapy technique (IMRT/SRT/SBRT/VMAT, etc.), and large-segment radiotherapy.
- Subjects have no major organ dysfunction, or laboratory test indicators must meet the following requirements: Hematology: normal range according to laboratory standards; cardiac function: normal range; liver function: normal range; renal function: normal range Lung function: FEV1>50%, impaired light-moderate lung function.
- Informed consent (radiation, medication) before treatment;
- The patient has good compliance with the treatment and follow-up received.
Who cannot join
- Patients who do not meet the pathological type, stage, and survival status of the inclusion criteria;
- no malignant pleural effusion IV stage NSCLC;
- patients with malignant pericardial effusion; Diffuse liver metastasis, intrapulmonary metastasis and has seriously affected patients with liver and lung function;
- Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, or symptomatic congestive heart failure or uncontrolled arrhythmias in the past 12 months; clinically diagnosed heart valve disease; • • •Active period of disease caused by bacteria, fungi or viruses; mental disorders; impaired severe lung function;
- pregnant, lactating patients;
- Patients with a history of other active malignancies other than small cell lung cancer before entering the group; non-melanoma skin basal cell carcinoma, in situ cervical cancer, and cured early prostate cancer;
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- Patients with allergies and no known alternatives to known or suspected drugs in any study;
- Patients with poor compliance;
- Researchers believe that it is not appropriate to participate in this test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guizhou Cancer Hospital
Guiyang, Guizhou, 550004
Lu Bing, MD, 86-13765066737, 574679514@qq.com
About this study
Official title: A Randomized Phase II Trial of Primary Tumor Radiotherapy for Patients With Malignant Pleural Effusion Stage IV Non-Small Cell Lung Cancer
This randomized phase II study compare survival outcomes and toxicity of malignant pleural effusion stage IV non small-cell lung cancer patients Intrapleural infusion chemotherapy in combination with concurrent thoracic radiation therapy (TRT) VS not combination with concurrent thoracic radiation therapy (TRT).
Read the detailed description
Malignant pleural effusion (MPE) is a common complication of stage IV NSCLC. MPE caused by lung cancer accounts for about 1/3. According to statistics, the number of MPE cases per year in the United States exceeds 150,000. At the same time, with the development of three-dimensional radiotherapy technology, the wide application of comprehensive treatment concept, and the understanding of the relationship between different metastatic state and survival of stage IV NSCLC, prospective and retrospective studies have confirmed that systemic therapy combined with primary tumor three-dimensional radiation Treatment is more conducive to improving symptoms and prolonging survival than medication alone. Retrospective results and prospective findings have been reported from the single center of the study group [Chinese Journal of Radiation Oncology, 2011, sixth issue and the first issue of 2012], taking local three-dimensional radical radiotherapy for chemotherapy, two Complementary technological advantages can significantly prolong survival and improve quality of life, enabling some patients to achieve long-term survival. However, most of the above studies excluded patients with malignant pleural effusion. For stage IV NSCLC of malignant pleural effusion, whether the primary tumor radiotherapy can bring survival benefits, has not yet formed a unified norm and conclusion, and needs further development. the study.
- Being tested
- Radiation, Chemotherapy
- Medical subject headings
- Pleural Effusion, Malignant, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Thoracic intensity modulated radiation therapy (IMRT)
+EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy
ChemotherapyDrug
EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy group | Experimental | Thoracic intensity modulated radiation therapy (IMRT) concomitant with EGFR-TKI on paticipants with known sensitive EGFR mutations.Cisplatin Thoracenteral infusion chemotherapy。 Thoracic intensity modulated radiation therapy (IMRT) concomitant with Cisplatin Thoracenteral infusion chemotherapy and Systemic chemotherapy on paticipants with known NOT sensitive EGFR mutations. Receives: Radiation: Radiation |
| Chemotherapy group | Active comparator | EGFR-TKI on paticipants with known sensitive EGFR mutations,Cisplatin Thoracenteral infusion chemotherapy.
Cisplatin Thoracenteral infusion chemotherapy and Systemic chemotherapy on paticipants with known NOT sensitive EGFR mutations. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: up to 9 months
Secondary outcomes (2)
Overall survival(OS)
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause Overall survival is defined as the time interval from date of diagnosis to date of death from any cause Overall survival is defined as the time interval from date of diagnosis to date of death from any cause Overall survival is defined as the time interval from date of diagnosis to date of death from any cause Overall survival is defined as the time interval from date of diagnosis to date of death from any cause
Measured: Time Frame: up to 9 months
Treatment toxicities
To assess and record nausea, vomiting, hematologic toxicity,radiation oesophagitis and other treantment complications by CTCAE v4.0
Measured: Time Frame: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Sep 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987087
- Sponsor's protocol ID
- IV-NSCLC-MPE
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Primary Tumor Radiotherapy for Patients With Malignant Pleural Effusion Stage IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03987087
- Acronym / sponsor ID
- IV-NSCLC-MPE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 14 Jun 2019 (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.
This randomized phase II study compare survival outcomes and toxicity of malignant pleural effusion stage IV non small-cell lung cancer patients Intrapleural infusion chemotherapy in combination with concurrent thoracic radiation therapy (TRT) VS not combination with concurrent thoracic radiation therapy (TRT).
Detailed description
Malignant pleural effusion (MPE) is a common complication of stage IV NSCLC. MPE caused by lung cancer accounts for about 1/3. According to statistics, the number of MPE cases per year in the United States exceeds 150,000. At the same time, with the development of three-dimensional radiotherapy technology, the wide application of comprehensive treatment concept, and the understanding of the relationship between different metastatic state and survival of stage IV NSCLC, prospective and retrospective studies have confirmed that systemic therapy combined with primary tumor three-dimensional radiation Treatment is more conducive to improving symptoms and prolonging survival than medication alone. Retrospective results and prospective findings have been reported from the single center of the study group [Chinese Journal of Radiation Oncology, 2011, sixth issue and the first issue of 2012], taking local three-dimensional radical radiotherapy for chemotherapy, two Complementary technological advantages can significantly prolong survival and improve quality of life, enabling some patients to achieve long-term survival. However, most of the above studies excluded patients with malignant pleural effusion. For stage IV NSCLC of malignant pleural effusion, whether the primary tumor radiotherapy can bring survival benefits, has not yet formed a unified norm and conclusion, and needs further development. the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy group | Experimental | Radiation: RadiationThoracic intensity modulated radiation therapy (IMRT) concomitant with EGFR-TKI on paticipants with known sensitive EGFR mutations.Cisplatin Thoracenteral infusion chemotherapy。 Thoracic intensity modulated radiation therapy (IMRT) concomitant with Cisplatin Thoracenteral infusion chemotherapy and Systemic chemotherapy on paticipants with known NOT sensitive EGFR mutations. |
| Chemotherapy group | Active comparator | Drug: ChemotherapyEGFR-TKI on paticipants with known sensitive EGFR mutations,Cisplatin Thoracenteral infusion chemotherapy. Cisplatin Thoracenteral infusion chemotherapy and Systemic chemotherapy on paticipants with known NOT sensitive EGFR mutations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with pathological or cytological diagnosis, stage IV with malignant pleural effusion [UICC 2017 staging eighth edition] NSCLC patients;
- initial treatment (previously did not receive any treatment), it is recommended to complete the detection of driver genes (EGFR / ALK / ROS1) (tissue, blood);
- Age 18 to 80 years old, physical status score ECOG 0 to 2 or KPS ≥ 70 (see Annex 2); Metastatic lesions in the distant area: conscious when brain metastasis; the number of metastatic lesions in the lung does not affect lung function and may be treated with primary and/or partial metastases;
- no radiotherapy, EGFR-TKI and chemotherapy contraindications;
- primary tumor radiotherapy requires IMRT technology;
Key exclusion criteria (9 listed)
- Patients who do not meet the pathological type, stage, and survival status of the inclusion criteria;
- no malignant pleural effusion IV stage NSCLC;
- patients with malignant pericardial effusion; Diffuse liver metastasis, intrapulmonary metastasis and has seriously affected patients with liver and lung function;
- Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, or symptomatic congestive heart failure or uncontrolled arrhythmias in the past 12 months; clinically diagnosed heart valve disease; • • •Active period of disease caused by bacteria, fungi or viruses; mental disorders; impaired severe lung function;
- pregnant, lactating patients;
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 |
|---|---|---|
| RadiationThoracic intensity modulated radiation therapy (IMRT) +EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy | Radiation | Radiotherapy group |
| ChemotherapyEGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy | Drug | Chemotherapy group |
Primary outcome
Progression-free survival(PFS)
Time frame: up to 9 months
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
2 secondary outcomes
Overall survival(OS)
Time frame: Time Frame: up to 9 months
Treatment toxicities
Time frame: Time Frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Radiation and Chemotherapy in people with Malignant Pleural Effusion and Nonsmall Cell Lung Cancer, Stage IV, run by Guizhou Medical University at 1 site in China.
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 11 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: status not confirmed, as of the sponsor's last update on 14 Jun 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YiChao Geng, MD (0086-851-86513076, 574679514@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: up to 9 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 14 Jun 2019.