Drug-Related Side Effects and Adverse ReactionsNCT03177174
Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
A study testing Cisplatin and Docetaxel in people with Drug-Related Side Effects and Adverse Reactions, run by Luo yanrong at 1 site in China.
Trial summary
This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Drug-Related Side Effects and Adverse Reactions
- What is being tested?
- Cisplatin and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2017to 1 Feb 2020
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18, <70 years old, with locally advanced nasopharyngeal carcinoma.
Who cannot join
- patients who had accepted radiotherapy before patients with any ather types of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the General Hospital of PLA
This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.
- Keywords
- locally advanced nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Toxic reaction
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Active comparator | Not described Receives: Drug: Docetaxel |
| Cisplatin | Active comparator | Not described Receives: Drug: Cisplatin |
| DocetaxelCisplatin | Active comparator | Cisplatin combined with Docetaxel Receives: Drug: Cisplatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in toxic reaction
incidence rate of the toxic reaction between three groups
Measured: 5 years
Secondary outcomes (1)
over survival
differences of over survival rate between three groups
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start12 Jun 2017
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
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 Drug-Related Side Effects and Adverse ReactionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luo yanrong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luo yanrong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177174
- Sponsor's protocol ID
- S2017-030-02
- Status last verified
- Feb 2020
- First submitted
- 18 Mar 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo Y, Cai B, Li B, Liu F, Du L, Zhao D, Fan W, Meng L, Zhang X, Ma L. The Acute Toxicities and Efficacy of Concurrent Chemotherapy With Docetaxel Plus Cisplatin, or Docetaxel, or Cisplatin and Helical Tomotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Single-Center Phase II Trial. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221109974. doi: 10.1177/15330338221109974.
PubMed 35770295
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the General Hospital of PLA
- ClinicalTrials.gov ID
- NCT03177174
- Acronym / sponsor ID
- S2017-030-02
- Keywords
- locally advanced nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Toxic reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Luo yanrongUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 6 Jun 2017 (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 study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Active comparator | Drug: Docetaxel |
| Cisplatin | Active comparator | Drug: Cisplatin |
| DocetaxelCisplatin | Active comparator | Drug: Cisplatin, Drug: DocetaxelCisplatin combined with Docetaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients > 18, <70 years old, with locally advanced nasopharyngeal carcinoma.
Key exclusion criteria (1 listed)
- patients who had accepted radiotherapy before patients with any ather types of cancer
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 |
|---|---|---|
| Cisplatinradiotherapy combined with Chemotherapy Drugs, Cancer | Drug | Cisplatin, DocetaxelCisplatin |
| DocetaxelDocetaxel | Drug | Docetaxel, DocetaxelCisplatin |
Primary outcome
changes in toxic reaction
Time frame: 5 years
incidence rate of the toxic reaction between three groups
1 secondary outcome
over survival
Time frame: 5 years
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 7 Feb 2020.
- Derived from this study: PubMed 35770295Luo Y, Cai B, Li B, Liu F, Du L, Zhao D, Fan W, Meng L, Zhang X, Ma L. The Acute Toxicities and Efficacy of Concurrent Chemotherapy With Docetaxel Plus Cisplatin, or Docetaxel, or Cisplatin and Helical Tomotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Single-Center Phase II Trial. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221109974. doi: 10.1177/15330338221109974.
- Individual participant dataSharing planned: No
Related trials for Drug-Related Side Effects and Adverse Reactions
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Not yet recruitingPhase 1
Safety and Tolerability of Single and Repeated Dose of IMM02-KORA in PD-associated Dyskinesia
Dyskinesia, Medication-induced, Dyskinesia, Drug-Induced
Active, not recruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Melanoma Stage III, Melanoma Stage IV
Active, not recruiting
Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
Drug-Related Side Effects and Adverse Reaction, Digoxin Overdose
RecruitingPhase 3
S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
Cardiotoxicity, HER2/Neu Positive
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cisplatin and Docetaxel in people with Drug-Related Side Effects and Adverse Reactions, run by Luo yanrong 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 1 inclusion and 1 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 7 Feb 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 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.
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?
changes in toxic reaction (time frame: 5 years). 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 NCT03177174, 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 7 Feb 2020.