NCT05564286

Brief Summary

The study is to evaluate the antiemetic effect of adding fosaprepitant to biplet regimen of tropisetron and dexamethasone for patients with cervical cancer or nasopharyngeal cancer treated with radiotherapy and concomitant weekly cisplatin chemotherapy in a south Chinese cohort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

September 29, 2022

Last Update Submit

February 3, 2024

Conditions

Cervical CancerNasopharyngeal CancerChemotherapy-induced Nausea and VomitingRadiation-Induced Nausea and VomitingAntiemetic

Outcome Measures

Primary Outcomes (1)

  • cumulative incidence of emesis overall phase

    The primary endpoint of the study was the cumulative incidence of emesis overall phase (from 1st day of cycle 1 to 7th day of cycle 5, 7 days for one cycle).

    5 weeks

Study Arms (2)

fosaprepitant group

EXPERIMENTAL

Intravenous fosaprepitant of 150mg was given before cisplatin administration on day 1. All patients received tropisetron 5mg and dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.

Drug: FosaprepitantDrug: tropisetronDrug: Dexamethasone

control group

ACTIVE COMPARATOR

The control group was delivered tropisetron 5mg and dexamethasone 5mg only.

Drug: tropisetronDrug: Dexamethasone

Interventions

FosaprepitantDRUG

In fosaprepitant group, patients would receive fosaprepitant combined with tropisetron plus dexamethasone to prevent chemoradiotherapy-induced nausea and vomitting while the control group would only be given tropisetron and dexamethasone .

Also known as: shanqi
fosaprepitant group
tropisetronDRUG

All patients received tropisetron 5mg on day 1.

Also known as: luoting
control groupfosaprepitant group
DexamethasoneDRUG

.All patients received dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.

Also known as: xiluoan
control groupfosaprepitant group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed nasopharyngeal carcinoma (AJCC 8th stage II-IVa) or cervical cancer (adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma, clinical FIGO stage Ib2-IVa;), planning to receive concurrent chemoradiotherapy),18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

You may not qualify if:

  • took medications with antiemetic effect within 24 hours before initiation of concurrent chemoradiotherapy, had severe systemic diseases (such as uncontrolled diabetes/hypertension) or clinically unstable epileptic seizures require the use of anticonvulsants; allergic to fosaprepitant, tropisetron or dexamethasone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515031, China

Location

Related Publications (1)

  • Xie S, Huang R, Zhan Y, Cai Q, Wu Y, Huang K, Lin X, Wang R, Yan Y, Xie R, Wang S, Zeng C, Chen C. Efficacy of fosaprepitant combined with tropisetron plus dexamethasone in preventing nausea and emesis during fractionated radiotherapy with weekly cisplatin chemotherapy: interim analysis of a randomized, prospective, clinical trial using competing risk analysis. Support Care Cancer. 2023 Oct 18;31(12):640. doi: 10.1007/s00520-023-08111-9.

    PMID: 37851143DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsNasopharyngeal NeoplasmsVomiting

Interventions

fosaprepitantTropisetronDexamethasone

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Chuangzhen Chen

    Shantou University Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 3, 2022

Study Start

July 1, 2021

Primary Completion

July 31, 2023

Study Completion

August 30, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)