Status:
COMPLETED
A Trial of PTS Via Intratumoral Injection in Patients With Central Air Way NSCLC Severe Obstruction
Lead Sponsor:
PTS International Inc.
Conditions:
Nsclc
Eligibility:
All Genders
18-83 years
Phase:
PHASE3
Brief Summary
This trial was to evaluate the efficacy of intratumoral PTS injection in alleviating airway obstruction and dyspnea by improving the percentage of lumen patency of patients with central air way NSCLC ...
Detailed Description
1. Local intratumoral injection of para toluenesulfonamide (PTS) via bronchoscopy could alleviate airway obstruction for patients with central air way NSCLC tumor severe obstruction, which contributed...
Eligibility Criteria
Inclusion
- Male or female inpatients, aged 18 to 83 years old.
- Patients with central air way non-small cell lung cancer (NSCLC) severe obstruction; definition of severe airway obstruction: ≥1/2 trachea is obstructed by tumor; and/or block ≥2/3 of primary bronchi, right and middle bronchi. And the longest diameter of the lesion \> 0.5 cm.
- Pathologically confirmed lung cancer.
- Patients with tracheal tumor lesions suitable for local intratumoral injection via fibro-bronchoscopy.
- At least one measurable lesion that could be evaluated by imaging examination (bronchoscopy, CT, MRI or X-ray etc.) according to the Response Evaluation Criteria in Solid Tumors.
- Blood platelet count ≥ 100,000/mm3.
- Subjects who were able to understand and comply with the trial protocol and give written consent.
Exclusion
- Brain metastases.
- History of cardiovascular diseases, including congestive heart failure \> New York Heart Association (NYHA) Grade II. Patients with unstable angina pectoris (angina pectoris symptoms at rest), recent angina pectoris (occurred in the recent 3 months) or with myocardial infarction in recent 6 months must be excluded.
- Severe infections or dysbolism.
- Poor hepatic functional reserve or severe hepatocirrhosis, with abnormal blood coagulation indicators.
- Poor general conditions or cachexia.
- The target lesion had been treated with radiotherapy within 6 months.
- Pregnant or breast-feeding woman.
- Known hypersensitivity to PTS or related compounds.
- Lung cancer lesions not suitable for local treatment.
- Any other reason deemed reasonable by the investigator.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03448146
Start Date
August 1 2009
End Date
December 1 2011
Last Update
February 28 2018
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China