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

Primary Purpose

Malignant Pleural Effusion, Nonsmall Cell Lung Cancer, Stage IV

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radiation
Chemotherapy
Sponsored by
Guizhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guizhou Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiotherapy group

Chemotherapy group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Treatment toxicities
To assess and record nausea, vomiting, hematologic toxicity,radiation oesophagitis and other treantment complications by CTCAE v4.0

Full Information

First Posted
June 12, 2019
Last Updated
June 13, 2019
Sponsor
Guizhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03987087
Brief Title
A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC
Official Title
A Randomized Phase II Trial of Primary Tumor Radiotherapy for Patients With Malignant Pleural Effusion Stage IV Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guizhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion, Nonsmall Cell Lung Cancer, Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Chemotherapy group
Arm Type
Active Comparator
Arm Description
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 Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
Thoracic intensity modulated radiation therapy (IMRT) +EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy
Primary Outcome Measure Information:
Title
Progression-free survival(PFS)
Description
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Description
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
Time Frame
Time Frame: up to 9 months
Title
Treatment toxicities
Description
To assess and record nausea, vomiting, hematologic toxicity,radiation oesophagitis and other treantment complications by CTCAE v4.0
Time Frame
Time Frame: up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YiChao Geng, MD
Phone
0086-851-86513076
Email
574679514@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Lu, MD
Phone
0086-851-86513076
Email
chikyo@sina.com
Facility Information:
Facility Name
Guizhou Cancer Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Bing, MD
Phone
86-13765066737
Email
574679514@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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