Condition or disease | Intervention/treatment | Phase |
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Malignant Pleural Effusion Nonsmall Cell Lung Cancer, Stage IV | Radiation: Radiation Drug: Chemotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase II Trial of Primary Tumor Radiotherapy for Patients With Malignant Pleural Effusion Stage IV Non-Small Cell Lung Cancer |
Actual Study Start Date : | September 1, 2018 |
Estimated Primary Completion Date : | December 30, 2020 |
Estimated Study Completion Date : | December 30, 2021 |
Arm | Intervention/treatment |
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Experimental: Radiotherapy group
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.
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Radiation: Radiation
Thoracic intensity modulated radiation therapy (IMRT) +EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy |
Active Comparator: Chemotherapy group
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. |
Drug: Chemotherapy
EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: YiChao Geng, MD | 0086-851-86513076 | 574679514@qq.com | |
Contact: Bing Lu, MD | 0086-851-86513076 | chikyo@sina.com |
China, Guizhou | |
Guizhou Cancer Hospital | Recruiting |
Guiyang, Guizhou, China, 550004 | |
Contact: Lu Bing, MD 86-13765066737 574679514@qq.com |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 12, 2019 | ||||||||
First Posted Date ICMJE | June 14, 2019 | ||||||||
Last Update Posted Date | June 14, 2019 | ||||||||
Actual Study Start Date ICMJE | September 1, 2018 | ||||||||
Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC | ||||||||
Official Title ICMJE | A Randomized Phase II Trial of Primary Tumor Radiotherapy for Patients With Malignant Pleural Effusion Stage IV Non-Small Cell Lung Cancer | ||||||||
Brief 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). | ||||||||
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 Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
68 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 30, 2021 | ||||||||
Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03987087 | ||||||||
Other Study ID Numbers ICMJE | IV-NSCLC-MPE | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Guizhou Medical University | ||||||||
Study Sponsor ICMJE | Guizhou Medical University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Guizhou Medical University | ||||||||
Verification Date | June 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |