Non-small Cell Lung CancerNCT02364804
A Study to Evaluate the Efficacy of Anti-emetic Drug Upon the Combination Chemotherapy for Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Shiga University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Aprepitant
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2012to Sep 2015
- Phase
- Observational
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-small cell lung cancer patients who receive the combination chemotherapy of nedaplatin and docetaxel
Who may be able to join
- Patients who receive the combination chemotherapy of nedaplatin and docetaxel as a treatment or an adjuvant therapy for non-small cell lung cancer.
- ECOG performance status 0-1.
- Aged 20-79 years old.
- Laboratory values as follows 4000/mm3 < WBC < 12000/mm3, neutrophil count > 2000/mm3, platelet count > 100000/mm3, hemoglobin > 9.5g/dL, asparate transaminase < 2.5 X cutoff value, alanine transaminase < 2.5 X cutoff value, total bilirubin < 1.5g/dL, Serum creatinine < cutoff value, PaO2 > 60 Torr.
- Able and willing to give valid written informed consent.
Who cannot join
- Allergy against polysorbert 80 or platinum-containing drugs.
- Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, and hemorrhagic tendency).
- Active and uncontrolled infectious disease.
- Massive pleural or pericardial effusion.
- Other malignancy requiring treatment.
- Active interstitial pneumonitis or its past historyBreastfeeding and Pregnancy (woman of child bearing potential)
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- Peripheral nerve disorder.
- Pregnant or lactating women.
- Concurrent administration of pimozide.
- Decision of unsuitableness by principal investigator or physician-in-charge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Efficacy of Anti-emetic Drug Aprepitant Upon the Combination Chemotherapy of Nedaplatin and Docetaxel for Non-small Cell Lung Cancer
The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).
Read the detailed description
The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC). The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents except Aprepitant.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Aprepitant
- 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.
AprepitantDrug
Also called Emend
The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents but Aprepitant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting
Measured: Fifteen days after beginning of each cycle of chemotherapy
Secondary outcomes (1)
Influence on clinical outcome: Survival
Measured: Participants will be followed for 3 years 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 posted18 Feb 2015 (estimated)
- Study startApr 2012
- Primary completionMar 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiga University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yataro Daigo, Shiga University
- Investigators
- Yataro Daigo, MD, PhD, Principal investigator, Shiga University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364804
- Sponsor's protocol ID
- 24-20
- Status last verified
- Aug 2020
- First submitted
- 2 Feb 2015
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Anti-emetic Drug Aprepitant Upon the Combination Chemotherapy of Nedaplatin and Docetaxel for Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02364804
- Acronym / sponsor ID
- 24-20
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shiga UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Feb 2015 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).
Detailed description
The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC). The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents except Aprepitant.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-small cell lung cancer patients who receive the combination chemotherapy of nedaplatin and docetaxel
Key inclusion criteria (5 listed)
- Patients who receive the combination chemotherapy of nedaplatin and docetaxel as a treatment or an adjuvant therapy for non-small cell lung cancer.
- ECOG performance status 0-1.
- Aged 20-79 years old.
- Laboratory values as follows 4000/mm3 < WBC < 12000/mm3, neutrophil count > 2000/mm3, platelet count > 100000/mm3, hemoglobin > 9.5g/dL, asparate transaminase < 2.5 X cutoff value, alanine transaminase < 2.5 X cutoff value, total bilirubin < 1.5g/dL, Serum creatinine < cutoff value, PaO2 > 60 Torr.
- Able and willing to give valid written informed consent.
Key exclusion criteria (10 listed)
- Allergy against polysorbert 80 or platinum-containing drugs.
- Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, and hemorrhagic tendency).
- Active and uncontrolled infectious disease.
- Massive pleural or pericardial effusion.
- Other malignancy requiring treatment.
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 |
|---|---|---|
| AprepitantAlso: EmendThe incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents but Aprepitant. | Drug | – |
Primary outcome
Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting
Time frame: Fifteen days after beginning of each cycle of chemotherapy
1 secondary outcome
Influence on clinical outcome: Survival
Time frame: Participants will be followed for 3 years 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 1 Sep 2020.
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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.
Yataro Daigo, MD, PhD principal investigator
Shiga University of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Shiga University at 1 site in Japan.
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 5 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 1 Sep 2020. 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 Japan. 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.
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?
Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting (time frame: Fifteen days after beginning of each cycle of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2020.