Tracking Information

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Overall survival(OS) [ Time Frame: Time Frame: up to 9 months ]
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
Treatment toxicities [ Time Frame: Time Frame: up to 12 months ]
To assess and record nausea, vomiting, hematologic toxicity,radiation oesophagitis and other treantment complications by CTCAE v4.0

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

Condition ^ICMJE

Malignant Pleural Effusion
Nonsmall Cell Lung Cancer, Stage IV

Intervention ^ICMJE

Radiation: Radiation

Thoracic intensity modulated radiation therapy (IMRT)

+EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy
Drug: Chemotherapy
EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy

Study Arms ^ICMJE

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.

Intervention: Radiation: Radiation
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.

Intervention: Drug: Chemotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

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:

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;
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.

Exclusion Criteria:

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;
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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 80 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

No

Contacts ^ICMJE

Contact: YiChao Geng, MD	0086-851-86513076	574679514@qq.com
Contact: Bing Lu, MD	0086-851-86513076	chikyo@sina.com

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

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Undecided

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

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A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC

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