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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007638
Receipt No. 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

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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
Obsterics 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
Email 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
Email antira@faculty.chbia-u.jp

Sponsor
Institute chiba university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009011

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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