This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04636632
Recruitment Status : Completed
First Posted : November 19, 2020
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
Ming-Yuan Chen, Sun Yat-sen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: fosaprepitant Phase 1

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Weekly Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma: a Prospective Pilot Study
Actual Study Start Date : November 24, 2020
Actual Primary Completion Date : November 4, 2022
Actual Study Completion Date : November 4, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Weekly Arm
fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy
 Drug: fosaprepitant
fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy
Active Comparator: Triweekly Arm
fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy
 Drug: fosaprepitant
fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. the proportion of subjects with complete response (CR) overall [ Time Frame: 7 weeks ]
    defined as no emesis and no use of rescue therapy


Secondary Outcome Measures :
  1. the proportion of subjects with complete control (CC) overall [ Time Frame: 7 weeks ]
    defined as no emesis and no use of rescue therapy and no significant nausea

  2. the proportion of subjects with sustained no emesis overall [ Time Frame: 7 weeks ]
  3. the proportion of subjects with no nausea overall [ Time Frame: 7 weeks ]
  4. the proportion of subjects with no significant nausea overall [ Time Frame: 7 weeks ]
    defined as no or mild nausea

  5. the proportion of subjects with CR in the 24 hours following initiation of radiotherapy and concomitant cisplatin [ Time Frame: 24 hours ]
    defined as no emesis and no use of rescue therapy

  6. the proportion of subjects with CR in the 120 hours following initiation of radiotherapy and concomitant cisplatin [ Time Frame: 120 hours ]
    defined as no emesis and no use of rescue therapy

  7. the mean time to first emetic episode [ Time Frame: 7 weeks ]
  8. Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall [ Time Frame: 7 weeks ]
  9. Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) overall [ Time Frame: 7 weeks ]

Other Outcome Measures:
  1. Progress-free survival (PFS) [ Time Frame: 1 year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636632


Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Ming-Yuan Chen, MD,PhD Sun Yat-sen University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ming-Yuan Chen, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04636632    
Other Study ID Numbers: SYSUCC-MYC-2020-1104
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
 Stomatognathic Diseases
Otorhinolaryngologic Diseases
Fosaprepitant
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action