UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007638 |
|---|---|
| Receipt number | R000009011 |
| Scientific Title | A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by daily low-dose cisplatin-based concurrent chemoradiotherapy in patients with uterine cervical cancer. |
| Date of disclosure of the study information | 2012/04/02 |
| Last modified on | 2013/10/02 14:27:27 |
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Basic information
Public title
A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by daily low-dose cisplatin-based concurrent chemoradiotherapy in patients with uterine cervical cancer.
Acronym
A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by daily low-dose cisplatin-based concurrent chemoradiotherapy in patients with uterine cervical cancer.
Scientific Title
A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by daily low-dose cisplatin-based concurrent chemoradiotherapy in patients with uterine cervical cancer.
Scientific Title:Acronym
A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by daily low-dose cisplatin-based concurrent chemoradiotherapy in patients with uterine cervical cancer.
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 dexamethasone for nausea and vomiting at chemoradiation of patients with cervical cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary end point was the proportion of patients with a CR (no emesis and no rescue medication) during chemoradiothyeapy (day 1-35)
Key secondary outcomes
(i) proportion of patients with complete control (CC: no emetic episode, no rescue
medication, and no more than mild nausea) during chemoradiothyeapy (day 1-35)
(ii)CR rate and CC rate each of during day1~7, day8~14, day 15~21, day 22~28 and day 29~35
(iii) Overall patient satisfaction with
antiemetic therapy was measured by a MASCC Antiemesis Tool (MAT) daily
(iv) time to treatment failure (TTF: time to first emetic episode or first administration of rescue medication).
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 x25) with daily low-dose cisplatin (8.0 mg/m2/day)
Palonosetron (0.75 mg) as a single fixed intravenous dose 30 min before chemotherapy
initiation on day 1, 8, 15, 22, 29.
Dexamethosone (4 mg orally) was administered on days 1-35.
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
1) Histologically confirmed uterine cervical cancer (squqmous cell carcinoma ,adenocarcinoma and adenosquamous cell carcinoma)
2) Clinical stage IB2-IVa patients who planned daily low-dose cisplatin-based concurrent chemoradiotherapy
3) Aged 20 years or more
4) ECOG Performance Status 0-2
5) Adequate bone-marrow function, renal function, liver function
6) Fully written informed consent.
Key exclusion criteria
1) severe, uncontrolled, concurrent illness other than neoplasia;
2) asymptomatic metastases to the brain;
3) seizure disorder needing anticonvulsants unless clinically stable;
4) uncontrolled pleural effusion or ascites;
5) gastric outlet orintestinal obstruction;
6) any vomiting, retching, or grade 2or higher nausea according to CTCAE;
7) a known hypersensitivity to palonosetron, granisetron, or other 5-HT3-receptor antagonists or dexamethasone ingredients;
8) Between registration and administration of the study drug, patients who met the following discontinuation criteria were withdrawn from the study: appeared not to
be eligible; received an antiemetic drug within 24 h before administration of study drug; and vomiting, retching, or grade 2 or higher nausea according to CTCAE within 24 h before administration of study drug.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makio Shozu |
Organization
Graduate School of Medicine, Chiba University
Division name
Reproductive medicine
Zip code
Address
1-8-1 inohana chouku chiba japan
TEL
043-222-7171
shozu@faculty.chbia-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | akra mitsuhashi |
Organization
Graduate School of Medicine, Chiba University
Division name
Reproductive medicine
Zip code
Address
1-8-1 ihohana chuoku chiba japan
TEL
043-222-7171
Homepage URL
antira@faculty.chbia-u.jp
Sponsor or person
Institute
chiba university
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
| 2012 | Year | 04 | 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
| 2011 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
| 2012 | Year | 04 | Month | 02 | Day |
Last modified on
| 2013 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009011
