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Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer

Primary Purpose

Cervical Cancer, Nasopharyngeal Cancer, Chemotherapy-induced Nausea and Vomiting

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Fosaprepitant
tropisetron
Dexamethasone
Sponsored by
Shantou University Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cancer Hospital of Shantou University Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fosaprepitant group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

cumulative incidence of emesis overall phase
the cumulative incidence of emesis from 1st day of cycle 1 to 7th day of cycly 5 of chemotherapy

Secondary Outcome Measures

Full Information

First Posted
September 29, 2022
Last Updated
September 29, 2022
Sponsor
Shantou University Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05564286
Brief Title
Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer
Official Title
Fosaprepitant Combined With Tropisetron Plus Dexamethasone in Preventing Nausea and Emesis During Fractionated Radiotherapy With Weekly Cisplatin Chemotherapy in Cervical Cancer and Nasopharyngeal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shantou University Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.
Detailed Description
The study was designed as a prospective,randomized, single-blind control clinical trial aiming to assess the efficacy and safety of fosaprepitant combined with tropisetron and dexamethasone in preventing nausea and vomiting during 5 weeks of fractionated radiotherapy and concomitant weekly low-dose cisplatin chemotherapy in patients with cervical cancer or nasopharyngeal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Nasopharyngeal Cancer, Chemotherapy-induced Nausea and Vomiting, Radiation-Induced Nausea and Vomiting, Antiemetic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fosaprepitant group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The control group was delivered tropisetron 5mg and dexamethasone 5mg only.
Intervention Type
Drug
Intervention Name(s)
Fosaprepitant
Other Intervention Name(s)
shanqi
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
tropisetron
Other Intervention Name(s)
luoting
Intervention Description
All patients received tropisetron 5mg on day 1.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
xiluoan
Intervention Description
.All patients received dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.
Primary Outcome Measure Information:
Title
cumulative incidence of emesis overall phase
Description
the cumulative incidence of emesis from 1st day of cycle 1 to 7th day of cycly 5 of chemotherapy
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuangzhen Chen
Phone
+86 13923995569
Email
czchen2@stu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuangzhen Chen
Organizational Affiliation
Shantou University Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuangzhen Chen, MD
Email
stccz@139.com
First Name & Middle Initial & Last Name & Degree
Jianzhou Chen, MD, PhD
Email
cjzeoeo@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer

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