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

NCT03987087 | Unknown Phase 2 DMC

• 1 other identifier: IV-NSCLC-MPE
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Malignant Pleural Effusion; Nonsmall Cell Lung Cancer, Stage IV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival(OS)

  Time Frame: up to 9 months

• Treatment toxicities

  Time Frame: up to 12 months

Study Arms (2)

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.

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.

Drug: Chemotherapy

Interventions

Radiation RADIATION

Thoracic intensity modulated radiation therapy (IMRT) +EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy

Radiotherapy group

Chemotherapy DRUG

EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy

Chemotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guizhou Medical University: lead

Study Sites (1)

Guizhou Cancer Hospital

Guiyang, Guizhou, 550004, China

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant; Carcinoma, Non-Small-Cell Lung

Interventions

Radiation; Drug Therapy

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Lung Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Therapeutics

Central Study Contacts

YiChao Geng, MD

CONTACT

0086-851-86513076; 574679514@qq.com

Bing Lu, MD

CONTACT

0086-851-86513076; chikyo@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 14, 2019
• Study Start: September 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: June 14, 2019

Record last verified: 2019-06

Locations

CN (1)