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Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients

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ClinicalTrials.gov Identifier: NCT02579564
Recruitment Status : Unknown
Verified October 2016 by Zhengtang Chen, Xinqiao Hospital of Chongqing.
Recruitment status was:  Not yet recruiting
First Posted : October 19, 2015
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Zhengtang Chen, Xinqiao Hospital of Chongqing

Study Description
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Brief Summary:
The purpose of this multi-center clinical trial is to verify more effective on local control of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar) compared with cisplatin perfusion, with acceptable side effects.

Condition or disease Intervention/treatment Phase
Malignant Hydrothorax Non Small Cell Lung Cancer Drug: Gemcitabine Drug: Vinorelbine Drug: Paclitaxel Drug: Pemetrexed Drug: Oncorine Drug: Endostar Drug: Cisplatin Phase 3

Detailed Description:
Malignant pleural effusion, which can malfunction of circulatory and respiratory systems, is a common complication in advanced NSCLC, finally decreases the quality of life and lifespan. Nowadays, it is still a challenge to effectively control malignant pleural effusion. In this multi-center randomized and controlled clinical trial, 134 NSCLC patients diagnosed as malignant pleural effusion in the first time will enroll. Based on systemic chemotherapy and pleural cavity perfusion, all eligible patients are randomly assigned into treatment group (recombinant human adenovirus type 5 and Endostatin injections) and control group (cisplatin) with ratio 1:1. Local control rate and side effects are record respectively. The anticipation is that treatment group obtains faster and longer control of pleural effusion.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systemic Chemotherapy Combined With Thoracic Cavity Perfusion of Recombinant Human Adenovirus Type 5 and Endostatin Injections Versus Cisplatin for Treatment Malignant Hydrothorax in Non Small Cell Lung Cancer (NSCLC) Patients: A Multi-center, Randomized, Controlled Clinical Trial
Study Start Date : October 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: chemotherapy with Oncorine and Endostar
Systemic chemotherapy with standard schemes, such as GP (Gemcitabine/Cisplatin), NP (Vinorelbine/Cisplatin), TP (Paclitaxel/Cisplatin) or PP (Pemetrexed/Cisplatin). Thoracic cavity perfusion of recombinant human adenovirus type 5 injection 1.5ml and Endostar 30mg each time, twice a week for four times.
 Drug: Gemcitabine
Drug: Vinorelbine
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Oncorine
Other Name: recombinant human adenovirus type 5 injection

Drug: Endostar
Other Name: recombinant human endostatin injection

Drug: Cisplatin
Active Comparator: chemotherapy with cisplatin
Systemic chemotherapy with standard schemes without cisplatin, such as Gemcitabine, Vinorelbine, Paclitaxel or Pemetrexed. Thoracic cavity perfusion of cisplatin 30mg/m2 each time, twice a week for four times.
 Drug: Gemcitabine
Drug: Vinorelbine
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) of malignant pleural effusions [ Time Frame: up to 3 years ]
    Assessed by WHO Cancerous effusion scoring system


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: up to 3 years ]

Other Outcome Measures:
  1. quality of life [ Time Frame: up to 3 years ]
    Assessed by Karnofsky Performance Status(KPS)

  2. side effects [ Time Frame: up to 3 years ]
    Assessed by NCI CTC3.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18-75 yrs;
  2. Kamofsky score (KPS) ≥70, and a predicted lifespan >3 months;
  3. Enough function of vital organs, such as heart, liver and kidney;
  4. Advanced NSCLC diagnosed by cytology or pathology
  5. Unilateral or bilateral of malignant pleural effusion in the first time;
  6. Patients who are considered as malignant pleural effusion by cytology or biomarkers (CEA, CA199, CA125) in pleural effusion;
  7. Without systemic infection or high fever;
  8. Without active EGFR mutation or unwilling to targeted molecular therapy;
  9. NO Anti tumor Radiotherapy chemotherapy and molecular targeted therapy,or Received Anti tumor Radiotherapy chemotherapy and molecular and clinical remission more than three months and in the past month ,disease progress with pleural cavity effusion but haven't use systemic or local anti tumor treatment.
  10. No pleural cavity injection of antineoplastic drugs.

Exclusion Criteria:

  1. Non-malignant pleural effusion;
  2. Pleural effusion cause by other malignant tumors;
  3. Allergic to Recombinant human adenovirus type 5 injection or Endostar;
  4. Pregnant or lactation women;
  5. Previously using Medicine for treating NSCLC with pleural cavity effusion by Systemic or pleural cavity perfusion treatment one month prior to enrollment;
  6. Previously using the diuretics, albumin and anti-angiogenesis drugs, or dexamethasone one month prior to enrollment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579564


Contacts
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Contact: ZhengTang Chen, PHD +862368755625 1240887467@qq.com

Sponsors and Collaborators
Xinqiao Hospital of Chongqing
More Information
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Responsible Party: Zhengtang Chen, Chief Physician, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT02579564     History of Changes
Other Study ID Numbers: CTAEMTF
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Hydrothorax
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pleural Diseases
Gemcitabine
Paclitaxel
Vinorelbine
 Albumin-Bound Paclitaxel
Cisplatin
Pemetrexed
Endostar protein
Endostatins
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents