Esophageal NeoplasmsPhase 2NCT02937519
Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
A Phase 2 study testing Chrono-chemotherapy pump:Melodie, Routine intravenous drip and induction Chrono-chemotherapy in people with Esophageal Neoplasms, run by Guiyang Medical University at 1 site in China.
Trial summary
1. Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy term efficacy of the treatment of locally advanced nasopharyngeal carcinoma. 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Chrono-chemotherapy pump:Melodie, Routine intravenous drip and induction Chrono-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
- Jun 2015to Jun 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.
- KPS≥70 points.
- the age of 18-70 years old, male or female.
- no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / 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 upper limit of normal).
- understand this study and signed informed consent.
Who cannot join
- distant metastasis.
- who had received prior chemotherapy.
- patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
- pregnancy (via the urine or serum β-HCG test confirmed) or during lactation.
- serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Feng Jin, Bachelor, 0851-86512802, jinf8865@yahoo.com.cn
Feng Jin, Bachelor
About this study
Official title: Multi-center Phase II Clinical Randomized Study of Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
- Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy term efficacy of the treatment of locally advanced nasopharyngeal carcinoma.
- Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and tolerability.
3）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
- Esophageal Neoplasms
- Being tested
- Chrono-chemotherapy pump:Melodie, Routine intravenous drip, induction Chrono-chemotherapy, induction Routine-chemotherapy, cisplatin chrono-chemotherapy
- Keywords
- Chronomodulated Chemotherapy, Intensity Modulated Radiation Therapy, Advanced Nasopharyngeal Cancer
- Medical subject headings
- Esophageal Neoplasms
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 Chrono-chemotherapyDrug
induction Routine-chemotherapyDrug
cisplatin chrono-chemotherapyDrug
cisplatin routine-chemotherapyDrug
intensity-modulated radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Melodie group | Experimental | Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy Receives: Device: Chrono-chemotherapy pump:Melodie; Drug: induction Chrono-chemotherapy; Drug: cisplatin chrono-chemotherapy; Radiation: intensity-modulated radiation therapy |
| Routine-Chemotherapy | Other | Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy Receives: Device: Routine intravenous drip; Drug: induction Routine-chemotherapy; Drug: cisplatin routine-chemotherapy; Radiation: intensity-modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with curative effect
Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.
Measured: 1 year
Number of Participants with Adverse Events as a Measure of Safety
To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 3.0.
Measured: 5 years
Secondary outcomes (2)
Progression-free survival
Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.
Measured: 5 years
Overall survival
Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.
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 posted18 Oct 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guiyang Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University, Sun Yat-sen University
- Responsible party
- Principal investigator, Feng Jing, Guiyang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937519
- Sponsor's protocol ID
- 2016080201
- Status last verified
- Jun 2018
- First submitted
- 16 Aug 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Phase II Clinical Randomized Study of Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT02937519
- Acronym / sponsor ID
- 2016080201
- Conditions
- Esophageal Neoplasms
- Keywords
- Chronomodulated Chemotherapy, Intensity Modulated Radiation Therapy, Advanced Nasopharyngeal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Guiyang Medical UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University, Sun Yat-sen University
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 18 Oct 2016 (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.
- Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy term efficacy of the treatment of locally advanced nasopharyngeal carcinoma.
- Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and tolerability.
3）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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melodie group | Experimental | Device: Chrono-chemotherapy pump:Melodie, Drug: induction Chrono-chemotherapy, Drug: cisplatin chrono-chemotherapy, Radiation: intensity-modulated radiation therapyInduction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy |
| Routine-Chemotherapy | Other | Device: Routine intravenous drip, Drug: induction Routine-chemotherapy, Drug: cisplatin routine-chemotherapy, Radiation: intensity-modulated radiation therapyInduction routine-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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.
- KPS≥70 points.
- the age of 18-70 years old, male or female.
- no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / 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 upper limit of normal).
- understand this study and signed informed consent.
Key exclusion criteria (5 listed)
- distant metastasis.
- who had received prior chemotherapy.
- patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
- pregnancy (via the urine or serum β-HCG test confirmed) or during lactation.
- serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
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 |
| induction Chrono-chemotherapy | Drug | Melodie group |
| induction Routine-chemotherapy | Drug | Routine-Chemotherapy |
| cisplatin chrono-chemotherapy | Drug | Melodie group |
| cisplatin routine-chemotherapy | Drug | Routine-Chemotherapy |
| intensity-modulated radiation therapy | Radiation | Melodie group, Routine-Chemotherapy |
Primary outcome
Number of Participants with curative effect
Time frame: 1 year
Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.
Number of Participants with Adverse Events as a Measure of Safety
Time frame: 5 years
To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 3.0.
2 secondary outcomes
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: Yes
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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 Chrono-chemotherapy in people with Esophageal Neoplasms, run by Guiyang Medical University 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 5 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 6 Jun 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 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 Hang Jiang, Bachelor degree (0851-86512802, 233956010@qq.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 curative effect (time frame: 1 year). 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?
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 6 Jun 2018.