Nasopharyngeal CarcinomaPhase 1NCT04636632
Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
A Phase 1 study testing fosaprepitant in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is an opene-label, single center, randomized prospective pilot study to compare the efficacy of weekly versus triweekly fosaprepitant regimens for the prevention of nausea and emesis during concurrent chemoradiotherapy for nasopharyngeal carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- fosaprepitant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2020to 4 Nov 2022
- Phase
- Phase 1
- 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 with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- Stage II - IVa NPC patients (according to the 8th AJCC edition)
- Male and no pregnant female
- Scheduled for cisplatin-based induction chemotherapy (cisplatin≥ 70 mg/m2)and concomitant triweekly cisplatin
- Fosaprepitant sensitive (complete response [defined as no emesis and no use of rescue antiemetics] during the overall phase [0 to 120 hours] of all cycles of cisplatin-based induction chemotherapy)
- Age between 18-70
Show all 12Show fewer
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <2.0×upper limit of normal (ULN)
- Adequate renal function: creatinine clearance ≥60 ml/min
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70
- Without radiotherapy or chemotherapy
- Patients must give signed informed consent
Who cannot join
- Evidence of relapse or distant metastasis
- Pregnancy or lactation
- History of prior malignancy or previous treatment for NPC
- Had other current malignant diagnoses apart from non-melanoma skin cancers
- Emesis or clinically significant nausea (moderate or severe) in the 24 h before the first dose of study medication
- Drugs with antiemetic activity were not allowed for the 24 h before receiving the first dose of study medication
- Known history of central nervous system disease (e.g., a seizure disorder or brain metastases )
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weekly Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma: a Prospective Pilot Study
This is an opene-label, single center, randomized prospective pilot study to compare the efficacy of weekly versus triweekly fosaprepitant regimens for the prevention of nausea and emesis during concurrent chemoradiotherapy for nasopharyngeal carcinoma (NPC).
Read the detailed description
Scheme:
Eligible fosaprepitant sensitive (complete response [defined as no emesis and no use of rescue antiemetics] during the overall phase [0 to 120 hours] of all cycles of cisplatin-based induction chemotherapy) NPC patients will be randomized to 2 arms at 1:1 ratio.
- Weekly Arm: fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy.
- Triweekly Arm: fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- fosaprepitant
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fosaprepitantDrug
fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Weekly Arm | Experimental | fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy Receives: Drug: fosaprepitant |
| Triweekly Arm | Active comparator | fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy Receives: Drug: fosaprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of subjects with complete response (CR) overall
defined as no emesis and no use of rescue therapy
Measured: 7 weeks
Secondary outcomes (9)
the proportion of subjects with complete control (CC) overall
defined as no emesis and no use of rescue therapy and no significant nausea
Measured: 7 weeks
the proportion of subjects with sustained no emesis overall
Measured: 7 weeks
the proportion of subjects with no nausea overall
Measured: 7 weeks
the proportion of subjects with no significant nausea overall
defined as no or mild nausea
Measured: 7 weeks
the proportion of subjects with CR in the 24 hours following initiation of radiotherapy and concomitant cisplatin
defined as no emesis and no use of rescue therapy
Measured: 24 hours
the proportion of subjects with CR in the 120 hours following initiation of radiotherapy and concomitant cisplatin
defined as no emesis and no use of rescue therapy
Measured: 120 hours
the mean time to first emetic episode
Measured: 7 weeks
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall
Measured: 7 weeks
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) overall
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start24 Nov 2020
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
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 Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-Yuan Chen, MD,PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636632
- Sponsor's protocol ID
- SYSUCC-MYC-2020-1104
- Status last verified
- Nov 2022
- First submitted
- 10 Nov 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang Q, Zou X, Xie YL, Lin C, Ouyang YF, Liu YL, Duan CY, You R, Liu YP, Liu RZ, Huang PY, Guo L, Hua YJ, Chen MY. Fosaprepitant Weekly vs Every 3 Weeks for the Prevention of Concurrent Chemoradiotherapy-Induced Nausea and Vomiting: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2326127. doi: 10.1001/jamanetworkopen.2023.26127.
PubMed 37498596
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04636632
- Acronym / sponsor ID
- SYSUCC-MYC-2020-1104
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 19 Nov 2020 (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 is an opene-label, single center, randomized prospective pilot study to compare the efficacy of weekly versus triweekly fosaprepitant regimens for the prevention of nausea and emesis during concurrent chemoradiotherapy for nasopharyngeal carcinoma (NPC).
Detailed description
Scheme:
Eligible fosaprepitant sensitive (complete response [defined as no emesis and no use of rescue antiemetics] during the overall phase [0 to 120 hours] of all cycles of cisplatin-based induction chemotherapy) NPC patients will be randomized to 2 arms at 1:1 ratio.
- Weekly Arm: fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy.
- Triweekly Arm: fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Arm | Experimental | Drug: fosaprepitantfosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy |
| Triweekly Arm | Active comparator | Drug: fosaprepitantfosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- Stage II - IVa NPC patients (according to the 8th AJCC edition)
- Male and no pregnant female
- Scheduled for cisplatin-based induction chemotherapy (cisplatin≥ 70 mg/m2)and concomitant triweekly cisplatin
- Fosaprepitant sensitive (complete response [defined as no emesis and no use of rescue antiemetics] during the overall phase [0 to 120 hours] of all cycles of cisplatin-based induction chemotherapy)
Key exclusion criteria (8 listed)
- Evidence of relapse or distant metastasis
- Pregnancy or lactation
- History of prior malignancy or previous treatment for NPC
- Had other current malignant diagnoses apart from non-melanoma skin cancers
- Emesis or clinically significant nausea (moderate or severe) in the 24 h before the first dose of study medication
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 |
|---|---|---|
| fosaprepitantfosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy | Drug | Triweekly Arm, Weekly Arm |
Primary outcome
the proportion of subjects with complete response (CR) overall
Time frame: 7 weeks
defined as no emesis and no use of rescue therapy
9 secondary outcomes
the proportion of subjects with complete control (CC) overall
Time frame: 7 weeks
the proportion of subjects with sustained no emesis overall
Time frame: 7 weeks
the proportion of subjects with no nausea overall
Time frame: 7 weeks
the proportion of subjects with no significant nausea overall
Time frame: 7 weeks
the proportion of subjects with CR in the 24 hours following initiation of radiotherapy and concomitant cisplatin
Time frame: 24 hours
the proportion of subjects with CR in the 120 hours following initiation of radiotherapy and concomitant cisplatin
Time frame: 120 hours
the mean time to first emetic episode
Time frame: 7 weeks
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall
Time frame: 7 weeks
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) overall
Time frame: 7 weeks
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 Nov 2022.
- Derived from this study: PubMed 37498596Yang Q, Zou X, Xie YL, Lin C, Ouyang YF, Liu YL, Duan CY, You R, Liu YP, Liu RZ, Huang PY, Guo L, Hua YJ, Chen MY. Fosaprepitant Weekly vs Every 3 Weeks for the Prevention of Concurrent Chemoradiotherapy-Induced Nausea and Vomiting: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2326127. doi: 10.1001/jamanetworkopen.2023.26127.
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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.
Ming-Yuan Chen, MD,PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fosaprepitant in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 12 inclusion and 8 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 Nov 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
the proportion of subjects with complete response (CR) overall (time frame: 7 weeks). 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 NCT04636632, 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 Nov 2022.