- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03448146
A Trial of PTS Via Intratumoral Injection in Patients With Central Air Way NSCLC Severe Obstruction
February 27, 2018 updated by: PTS International Inc.
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
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.
Study Overview
Detailed Description
- 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 to the shrinkage of target tumor lesions in a short period, with an objective response rate of 66% and an improvement rate of luminal tumor obstruction of 70% in the end-of-treatment period.
- Patient's pulmonary function, atelectasis and quality of life were improved significantly after treatment, indicating that PTS treatment cuold relieve the symptoms of air way obstruction and provide clinical benefits to the patients.
- Adverse events were mainly blood streaked sputum, injection site haemorrhage, cough, pyrexia and oropharyngeal pain, without reporting of potential risks. Common study drug related adverse events included injection site haemorrhage, cough, and blood streaked sputum and oropharyngeal pain. The multi-center clinical study conducted strictly in accordance with Standard Operation Procedures for the Use of a Standard Bronchoscope in Local Intratumoral PTS Injection showed that PTS had good safety and tolerability and that the procedural risks of intratumoral PTS injection via bronchoscopy could be controlled.
- The advantages of PTS for treatment of airway lung cancer obstruction included significant efficacy, good safety, large applicable population; relatively simple equipment conditions and operation, thus it could be spread easily. PTS is also expected to be used in the treatment of central lung cancer with acute airway obstruction in combination with other treatments (such as stent implantation), which provides a new drug treatment to patients with airway lung cancer obstruction. PTS can complement with other treatments, which is expected to improve the treatment efficacy significantly.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Guangzhou, China
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 83 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Para-Toluenesulfonamide
The injection was provided 2-3 times a week, with 2 weeks as a cycle of treatment. No less than 4 times of PTS treatment were recomended for the first cycle of treatment, and for other cycles of treatment, the number of PTS injections could be adjusted appropriately based on the condition of the patient. |
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: 30 days after the last treatment
|
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
|
Improvement rate of luminal obstructions
Time Frame: 30 days after the last treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in FVC
Time Frame: 30 days after the last treatment
|
Changes in Forced Vital Capacity (FVC)
|
30 days after the last treatment
|
Change in FEV1/FVC
Time Frame: 30 days after the last treatment
|
Changes in Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC)
|
30 days after the last treatment
|
Change in BDI score
Time Frame: 30 days after the last treatment
|
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
|
Change in pleural effusion
Time Frame: 30 days after the last treatment
|
Changes in pleural effusion
|
30 days after the last treatment
|
Change in ECOG performance status
Time Frame: 30 days after the last treatment
|
Changes in Eastern Cooperative Oncology Group (ECOG) performance status
|
30 days after the last treatment
|
Change in QOL score
Time Frame: 30 days after the last treatment
|
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
|
Duration of response (DOR) of target lesion
Time Frame: 30 days after the last treatment
|
Duration of response (DOR) of target lesion
|
30 days after the last treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nan Shan Zhong, The First Affiliated Hospital of Guangzhou Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2009
Primary Completion (ACTUAL)
December 1, 2011
Study Completion (ACTUAL)
December 1, 2011
Study Registration Dates
First Submitted
February 11, 2018
First Submitted That Met QC Criteria
February 21, 2018
First Posted (ACTUAL)
February 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 28, 2018
Last Update Submitted That Met QC Criteria
February 27, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTS302
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nsclc
-
Shanghai Henlius BiotechCompleted
-
The Netherlands Cancer InstituteEnrolling by invitation
-
Centre Oscar LambretUniversity Hospital, LilleTerminated
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdCompleted
-
Bio-Thera SolutionsCompleted
-
Jiangsu Province Nanjing Brain HospitalRecruiting
-
TYK Medicines, IncRecruiting
-
Radboud University Medical CenterPfizer; ImaginAb, Inc.; University Hospital TuebingenNot yet recruitingNSCLCGermany, Netherlands
-
Beta Pharma, Inc.Completed
Clinical Trials on Para-Toluenesulfonamide
-
Gongwin Biopharm Co., Ltd.Recruiting
-
PTS International Inc.Withdrawn
-
Florida International UniversityUniversity of Southern California; Universidad Peruana Cayetano HerediaRecruitingHIV Infections | Sexually Transmitted Diseases | Hiv | Sexual Behavior | Risk Reduction | Sexually Transmitted Infections (Not HIV or Hepatitis)United States
-
Columbia UniversityNational Cancer Institute (NCI)Unknown
-
First Affiliated Hospital of Zhejiang UniversityRecruitingColorectal Cancer | Synchronous Isolated Para-aortic Lymph Node MetastasisChina
-
Hospital Universitari Vall d'Hebron Research InstituteFundación Mutua MadrileñaCompletedOvarian Neoplasms | Endometrial NeoplasmsSpain
-
Humanitas Hospital, ItalyRecruitingPancreas Adenocarcinoma | Pancreas Cancer | Pancreaticoduodenal LymphadenopathyItaly
-
University of Alabama at BirminghamRobert Wood Johnson Foundation; UAB Diabetes Research Center; UAB Nutrition Obesity... and other collaboratorsCompleted
-
Arizona State UniversityCompletedDepression, Postpartum | Overweight and Obesity | Mother (Person)United States
-
University Hospital, MontpellierRecruitingInflammation | Low Back Pain | Degenerative Disc DiseaseFrance