Nasopharyngeal CarcinomaPhase 2NCT02187315
Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study
A Phase 2 study testing Chrono-chemotherapy pump:Melodie, Routine intravenous drip and induction chemotherapy in people with Nasopharyngeal Carcinoma, run by Feng Jing at 1 site in China.
Trial summary
Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Chrono-chemotherapy pump:Melodie, Routine intravenous drip and induction chemotherapy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Dec 2019
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions;
- Karnofsky score≥70;
- Age 18-70 years old, male or female;
- No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell ≥4．0×109／L，platelet≥100×109 /L. hemoglobin ≥100g/L)，normal liver function (total bilirubin、alanine aminotransferase、 aspartate aminotransferase ≤1.5 times the upper limit of normal)，normal renal function (creatinine ≤1.5 times the upper limit of normal) electrocardiogram does not affect the normal treatment;
- To understand this study and sign informed consent form.
Who cannot join
- A distant metastasis;
- Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;
- Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;
- Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Guiyang Medical College/The Affiliated Cancer Hospital of Guiyang Medical College/Guizhou Cancer Hospital
Guiyang, Guizhou, 550001
Feng Jin, Professor, +86 13985124806, jinf8865@gmail.com
About this study
Official title: Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With Intensity-modulated Radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma PhaseⅡClinical Randomized Study
Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Chrono-chemotherapy pump:Melodie, Routine intravenous drip, induction chemotherapy, cisplatin chrono-chemotherapy, intensity-modulated radiation therapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chrono-chemotherapy pump:MelodieDevice
Routine intravenous dripDevice
induction chemotherapyDrug
cisplatin chrono-chemotherapyDrug
intensity-modulated radiation therapyRadiation
cisplatin routine-chemotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Melodie group | Experimental | Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy Receives: Device: Chrono-chemotherapy pump:Melodie; Drug: induction chemotherapy; Drug: cisplatin chrono-chemotherapy; Radiation: intensity-modulated radiation therapy |
| Routine-chemotherapy group | Other | Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy Receives: Device: Routine intravenous drip; Drug: induction chemotherapy; Radiation: intensity-modulated radiation therapy; Drug: cisplatin routine-chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety
Measured: 5 year
Secondary outcomes (1)
Number of Participants with curative effect
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Jing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Jing, Guiyang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187315
- Sponsor's protocol ID
- 20140501
- Status last verified
- Jul 2014
- First submitted
- 15 May 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With Intensity-modulated Radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma PhaseⅡClinical Randomized Study
- ClinicalTrials.gov ID
- NCT02187315
- Acronym / sponsor ID
- 20140501
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Feng JingUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Jul 2014 (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.
Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melodie group | Experimental | Device: Chrono-chemotherapy pump:Melodie, Drug: induction chemotherapy, Drug: cisplatin chrono-chemotherapy, Radiation: intensity-modulated radiation therapyInduction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy |
| Routine-chemotherapy group | Other | Device: Routine intravenous drip, Drug: induction chemotherapy, Radiation: intensity-modulated radiation therapy, Drug: cisplatin routine-chemotherapyInduction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions;
- Karnofsky score≥70;
- Age 18-70 years old, male or female;
- No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell ≥4．0×109／L，platelet≥100×109 /L. hemoglobin ≥100g/L)，normal liver function (total bilirubin、alanine aminotransferase、 aspartate aminotransferase ≤1.5 times the upper limit of normal)，normal renal function (creatinine ≤1.5 times the upper limit of normal) electrocardiogram does not affect the normal treatment;
- To understand this study and sign informed consent form.
Key exclusion criteria (4 listed)
- A distant metastasis;
- Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;
- Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;
- Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.
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 |
|---|---|---|
| Chrono-chemotherapy pump:Melodie | Device | Melodie group |
| Routine intravenous drip | Device | Routine-chemotherapy group |
| induction chemotherapy | Drug | Melodie group, Routine-chemotherapy group |
| cisplatin chrono-chemotherapy | Drug | Melodie group |
| intensity-modulated radiation therapy | Radiation | Melodie group, Routine-chemotherapy group |
| cisplatin routine-chemotherapy | Drug | Routine-chemotherapy group |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety
Time frame: 5 year
1 secondary outcome
Number of Participants with curative effect
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chrono-chemotherapy pump:Melodie, Routine intravenous drip and induction chemotherapy in people with Nasopharyngeal Carcinoma, run by Feng Jing 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jul 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Jin, Professor (+86 13985124806, jinf8865@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety (time frame: 5 year). 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 11 Jul 2014.