UMIN-CTR Clinical Trial

Basic information
Public title	A single-blind randomized controlled trial comparing Aprepitant plus (Granisetron)1st 5-HT3 receptor antagonist and Palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies including CBDCA in the gynecology cancer patients.
Acronym	A single-blind randomized controlled trial for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies in the gynecology cancer patients.
Scientific Title	A single-blind randomized controlled trial comparing Aprepitant plus (Granisetron)1st 5-HT3 receptor antagonist and Palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies including CBDCA in the gynecology cancer patients.
Scientific Title:Acronym	A single-blind randomized controlled trial for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies in the gynecology cancer patients.
Region	Japan

Condition
Condition	Patients with gynecologic cancer receiving chemotherapy including carboplatin (that is, TC therapy: carboplatin + paclitaxel)
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of antiemetic therapy with palonosetron and dexamethasone with that of triple antiemetic therapy with a 5-HT3 receptor antagonist, dexamethasone and a NK1 receptor antagonist (fosaprepitant) for prevention of nausea and vomiting caused by chemotherapy including carboplatin in patients with gynecologic cancer, with the goal of finding improved antiemetic treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint was the percentage of patients with a complete response (no vomiting and no salvage treatment) throughout the first course of chemotherapy.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Antiemetic therapy with palonosetron and dexamethasone
Interventions/Control_2	Triple antiemetic therapy with a 5-HT3 receptor antagonist, dexamethasone and a NK1 receptor antagonist (fosaprepitant)
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. Patients with gynecologic cancer undergoing chemotherapy including carboplatin (>AUC 5) for the first time. 2. Patients in whom the regimen used in the first chemotherapy course is also planned for the second and later courses. 3. Patients who gave written consent to participation in the study.
Key exclusion criteria	1. Patients complicated with serious hepatic disorders or renal disorders. 2. Patients with nausea and vomiting within 24 hours before initiation of cancer chemotherapy. 3. Patients who used an antiemetic agent within 48 hours before initiation of cancer treatment. 4. Patients with nausea and vomiting due to causes (brain tumor, digestive passage disorders, active peptic ulcer, brain metastasis, use of opioids, etc.) other than cancer chemotherapy. 5. Patients with an associated disease, including uncontrolled diabetes, that prevents administration of dexamethasone for three days. 6. Patients under medication with pimozide. 7. Patients for whom abdominal radiotherapy is planned. 8. Patients with a history of vomiting in past chemotherapy. 9. Patients judged to be inappropriate for the study by the physician in charge.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Nao Middle name Last name Suzuki
Organization	St. Mariannna University, School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	2168511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL	044-977-8111
Email	nao@marianna-u.ac.jp

Public contact
Name of contact person	1st name Tatsuru Middle name Last name Ohara
Organization	St. Mariannna University, School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	2168511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL	044-977-8111
Homepage URL
Email	hffbd516@yahoo.co.jp

Sponsor
Institute	St. Mariannna University, School of Medicine
Institute
Department

Funding Source
Organization	NPO Kanagawa Supportive Care Group in Gynecologic Cancer(KSCGC)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Obstetrics and Gynecology,Tokai University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St. Mariannna University, School of Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel	044-977-8111
Email	sanpu@marianna-u.ac.jp

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	聖マリアンナ医科大学病院（神奈川県） 東海大学医学部付属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 01 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	Terminated
Date of protocol fixation	2012 Year 05 Month 01 Day
Date of IRB	2012 Year 05 Month 08 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 07 Month 27 Day
Last modified on	2021 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009961