UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011616 |
|---|---|
| Receipt number | R000012968 |
| Scientific Title | Efficacy of palonosetron plus aprepitant in preventing chemoradiotherapy-induced nausea and emesis in patients receiving daily low-dose cisplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a phase II study |
| Date of disclosure of the study information | 2013/09/02 |
| Last modified on | 2015/05/30 08:31:56 |
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Basic information
Public title
Efficacy of palonosetron plus aprepitant in preventing chemoradiotherapy-induced nausea and emesis in patients receiving daily low-dose cisplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a phase II study
Acronym
Efficacy of palonosetron plus aprepitant in preventing chemoradiotherapy-induced nausea and emesis in patients receiving daily low-dose cisplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a phase II study
Scientific Title
Efficacy of palonosetron plus aprepitant in preventing chemoradiotherapy-induced nausea and emesis in patients receiving daily low-dose cisplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a phase II study
Scientific Title:Acronym
Efficacy of palonosetron plus aprepitant in preventing chemoradiotherapy-induced nausea and emesis in patients receiving daily low-dose cisplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a phase II study
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of palonosetron and aprepitant for prevention of nausea and emesis during chemoradiation in patients with cervical cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy endpoints of this study were proportion of patients with complete response (defined as no emetic episodes and no rescue medication) during the overall phase.
Key secondary outcomes
The secondary endpoints were complete control (defined as no emetic episodes, no rescue medication, and no more than mild nausea), the number of emetic episodes, severity of nausea, adverse effect, time to administration of rescue therapy, and total dose of rescue dexamethasone.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The daily chemoradiation comprised pelvic external beam radiotherapy (2 Gy/day, 25 fractions, five times a week) with daily low-dose cisplatin (8 mg/m2/day).
All eligible patients received aprepitant (125 mg p.o.) and palonosetron (0.75 mg i.v.) before initiation of chemotherapy infusion on day 1 of each week. Aprepitant (80 mg p.o.) was administered on days 2 and 3 of each week
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
i) histologically confirmed uterine cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma)
ii) those with clinical stage IB2-IVa cancer in whom daily low-dose cisplatin-based concurrent chemoradiotherapy was planned as primary and adjuvant treatments
iii) no prior chemotherapy or radiotherapy
iv) age over 20 years with an Eastern Cooperative Oncology Group performance status of 0-2
v) adequate bone marrow, renal, and liver functions.
Key exclusion criteria
i) severe systemic or uncontrolled disease (uncontrolled diabetes mellitus or hypertension)
ii) asymptomatic metastases to the brain
iii) seizure disorder requiring anticonvulsants unless clinically stable
iv) uncontrolled pleural effusion or ascites
v) gastric outlet or intestinal obstruction
vi) a known hypersensitivity to palonosetron, granisetron, or other 5-HT3-receptor antagonists or dexamethasone ingredients. In the period between registration of patients and administration of the study drug, patients who met the following discontinuation criteria were withdrawn from the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Mitsuhashi |
Organization
Graduate School of Medicine, Chiba University
Division name
Reproductive Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
antira@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Mitsuhashi |
Organization
Graduate School of Medicine, Chiba University
Division name
Reproductive Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
antira@faculty.chbia-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 01 | Day |
Last modified on
| 2015 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012968
