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

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).

Study Overview

• Status: Unknown
• Conditions: Malignant Pleural Effusion; Nonsmall Cell Lung Cancer, Stage IV
• Intervention / Treatment: Radiation: Radiation; Drug: Chemotherapy

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: Interventional
• Enrollment (Anticipated): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • Recruiting
      • Guizhou Cancer Hospital
      • Contact: Lu Bing, MD; Phone Number: 86-13765066737; Email: 574679514@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Time Frame: up to 12 months

Collaborators and Investigators

• Sponsor: Guizhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: IV-NSCLC-MPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No