Nsclc Clinical Trial
Official title:
A Phase III Single Arm Trial of PTS (Para Toluenesulfonamide Injection) Via Bronchoscopy Intervention Intratumoral Injection in Patients With Central Air Way NSCLC Tumor Severe Obstruction
Verified date | February 2018 |
Source | PTS International Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 tumor severe obstruction.
Status | Completed |
Enrollment | 90 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 83 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou |
Lead Sponsor | Collaborator |
---|---|
PTS International Inc. |
China,
Li SY, Li Q, Guan WJ, Huang J, Yang HP, Wu GM, Jin FG, Hu CP, Chen LA, Xu GL, Liu SZ, Wu CG, Han BH, Xiang Y, Zhao JP, Wang J, Zhou X, Li HP, Zhong NS. Effects of para-toluenesulfonamide intratumoral injection on non-small cell lung carcinoma with severe — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate | The objective response rate of target lesions in patients with central air way NSCLC tumor severe obstruction after PTS treatment were evaluated based on measurement results of CT and bronchoscopy. | 30 days after the last treatment | |
Primary | Improvement rate of luminal obstructions | The improvement rate of luminal obstructions in patients with central air way NSCLC tumor severe obstruction after PTS treatment were evaluated based on measurement results of CT and bronchoscopy. | 30 days after the last treatment | |
Secondary | Change in FVC | Changes in Forced Vital Capacity (FVC) | 30 days after the last treatment | |
Secondary | Change in FEV1/FVC | Changes in Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) | 30 days after the last treatment | |
Secondary | Change in BDI score | Changes in Baseline Dyspnea Index (BDI) score. The BDI provides a multidimensional measurement of dyspnea based on 3 domains: functional impairment, magnitude of task and magnitude of effort that evoke dyspnea in activities of daily living, in symptomatic individuals. Rated in five grades from 0 to 4 for each domain. Ranging from 0 to 12. The lower the score, the worse the severity of dyspnea. | 30 days after the last treatment | |
Secondary | Change in pleural effusion | Changes in pleural effusion | 30 days after the last treatment | |
Secondary | Change in ECOG performance status | Changes in Eastern Cooperative Oncology Group (ECOG) performance status | 30 days after the last treatment | |
Secondary | Change in QOL score | Changes in Quality of Life (QOL) score. Quality of life (QOL) was evaluated based on the subject's answers in Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) questionnaire, version 4. Symptoms of lung cancer were evaluated according to the completed Lung Cancer Subscale (LCS). The FACT-LCS, version 4 is a patient completed questionnaire consisting 36 items that assesses health related quality of life (HRQL) in lung cancer patients. The FACT-LCS, version 4 consists of the 27-item FACT-G assessing generic HRQL concerns and 9-item Lung Cancer Subscale assessing disease-specific issues. Instrument scoring yields a range from 0 to 144 with higher scores representing better patient status. | 30 days after the last treatment | |
Secondary | Duration of response (DOR) of target lesion | Duration of response (DOR) of target lesion | 30 days after the last treatment |
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