NsclcPhase 3NCT03448146
A Trial of PTS Via Intratumoral Injection in Patients With Central Air Way NSCLC Severe Obstruction
A Phase 3 study testing Para-Toluenesulfonamide in people with Nsclc, run by PTS International Inc. at 1 site in China.
Trial 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 tumor severe obstruction. Read more about this study
- Who is it for?
- Ages 18 to 83 years
- Conditions the study is for
- Nsclc
- What is being tested?
- Para-Toluenesulfonamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
About this study
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
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.
Read the 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.
- Conditions
- Nsclc
- Being tested
- Para-Toluenesulfonamide
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Para-ToluenesulfonamideDrug
Also called PTS
| Study group | Role | What they receive |
|---|---|---|
| Para-Toluenesulfonamide | Experimental | 1. .The dose of PTS injected into multiple points in a single tumor was about 0.1-1.0 mL, and the appropriate specific doses were kept within the tumor without leakage. An appropriate low dose could be given firstly, and the following doses could be adjusted based on the response of patient and the tumor.
2. . In general, the daily dose of PTS injected into a single tumor was no more than 5mL, and the daily dose of PTS was no more than 10mL for each patient.
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. Receives: Drug: Para-Toluenesulfonamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after the last treatment
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.
Measured: 30 days after the last treatment
Secondary outcomes (7)
Change in FVC
Changes in Forced Vital Capacity (FVC)
Measured: 30 days after the last treatment
Change in FEV1/FVC
Changes in Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC)
Measured: 30 days after the last treatment
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.
Measured: 30 days after the last treatment
Change in pleural effusion
Changes in pleural effusion
Measured: 30 days after the last treatment
Change in ECOG performance status
Changes in Eastern Cooperative Oncology Group (ECOG) performance status
Measured: 30 days after the last treatment
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.
Measured: 30 days after the last treatment
Duration of response (DOR) of target lesion
Duration of response (DOR) of target lesion
Measured: 30 days after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study startAug 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NsclcStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- PTS International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nan Shan Zhong, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448146
- Sponsor's protocol ID
- PTS302
- Status last verified
- Feb 2018
- First submitted
- 11 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 central airway obstruction: A multi-center, non-randomized, single-arm, open-label trial. Lung Cancer. 2016 Aug;98:43-50. doi: 10.1016/j.lungcan.2016.05.012. Epub 2016 May 17.
PubMed 27393505
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03448146
- Acronym / sponsor ID
- PTS302
- Conditions
- Nsclc
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- PTS International Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Para-Toluenesulfonamide | Experimental | Drug: Para-Toluenesulfonamide1. .The dose of PTS injected into multiple points in a single tumor was about 0.1-1.0 mL, and the appropriate specific doses were kept within the tumor without leakage. An appropriate low dose could be given firstly, and the following doses could be adjusted based on the response of patient and the tumor. 2. . In general, the daily dose of PTS injected into a single tumor was no more than 5mL, and the daily dose of PTS was no more than 10mL for each patient. 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. |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Para-ToluenesulfonamideAlso: PTS | Drug | Para-Toluenesulfonamide |
Primary outcome
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.
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.
7 secondary outcomes
Change in FVC
Time frame: 30 days after the last treatment
Change in FEV1/FVC
Time frame: 30 days after the last treatment
Change in BDI score
Time frame: 30 days after the last treatment
Change in pleural effusion
Time frame: 30 days after the last treatment
Change in ECOG performance status
Time frame: 30 days after the last treatment
Change in QOL score
Time frame: 30 days after the last treatment
Duration of response (DOR) of target lesion
Time frame: 30 days after the last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Results publication: PubMed 27393505Li 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 central airway obstruction: A multi-center, non-randomized, single-arm, open-label trial. Lung Cancer. 2016 Aug;98:43-50. doi: 10.1016/j.lungcan.2016.05.012. Epub 2016 May 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nan Shan Zhong principal investigator
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Para-Toluenesulfonamide in people with Nsclc, run by PTS International Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 30 days after the last treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.