UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010186 |
|---|---|
| Receipt number | R000011926 |
| Scientific Title | Prospective, open-label, comparative study on the efficacy of triple (aprepitant + granisetron 3 mg + dexamethasone) versus double (palonosetron 0.75 mg + dexamethasone) combination therapy for nausea and vomiting during moderately emetogenic chemotherapy containing carboplatin: CAP Study |
| Date of disclosure of the study information | 2013/03/07 |
| Last modified on | 2015/11/04 12:08:23 |
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Basic information
Public title
Prospective, open-label, comparative study on the efficacy of triple (aprepitant + granisetron 3 mg + dexamethasone) versus double (palonosetron 0.75 mg + dexamethasone) combination therapy for nausea and vomiting during moderately emetogenic chemotherapy containing carboplatin: CAP Study
Acronym
CAP study
Scientific Title
Prospective, open-label, comparative study on the efficacy of triple (aprepitant + granisetron 3 mg + dexamethasone) versus double (palonosetron 0.75 mg + dexamethasone) combination therapy for nausea and vomiting during moderately emetogenic chemotherapy containing carboplatin: CAP Study
Scientific Title:Acronym
CAP study
Region
| Japan |
Condition
Condition
Malignancy treated with chemotherapy containing carboplatin
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In patients receiving carboplatin (CBDCA)-based moderately emetogenic chemotherapy (MEC), the efficacy of triple (aprepitant + granisetron 3 mg + dexamethasone) or double (palonosetron 0.75 mg + dexamethasone) combination antiemetic therapy will be compared after 1 course of chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of patients with complete protection (no vomiting, therapeutic intervention, or significant nausea) during the 1st course of treatment.
Key secondary outcomes
1) Percentage of patients with complete protection (CP: no vomiting, therapeutic intervention, or moderate to severe nausea) from the 2nd course of chemotherapy.
2) Percentage of patients with a complete response (CR: no vomiting or therapeutic intervention).
3) Percentage of patients with complete control (CC: no vomiting, therapeutic intervention, or nausea).
4) Percentage of patients without vomiting.
5) Percentage of patients without therapeutic intervention.
6) Percentage of patients without nausea.
7) Percentage of patients without significant nausea (CTCAE[ver.4] grade >=2).
8) Evaluation of the quality of life (QOL) related to nausea by using the Functional Living Index-Emesis (FLIE) questionnaire.
9) Food intake.
10) Total cost of medications (prevention + therapeutic intervention) for nausea/vomiting.
11) Percentage of patients continuing treatment.
12) Changes of nausea and vomiting (CP, CR, CC, etc.) over time (courses of chemotherapy).
13) Time-to-treatment failure (TTF: time to the first episode of vomiting).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
aprepitant (day1:125mg, day2,3:80mg)+ granisetron 3 mg + dexamethasone (day1:6.6mgIV, day2,3:2mgPOX2)
Interventions/Control_2
palonosetron 0.75 mg + dexamethasone(day1:9.9mgIV, day2,3:4mgPOX2)
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
Male and Female
Key inclusion criteria
1) Age: >=20 years.
2) Gender: Not specified.
3) Cancer patients receiving chemotherapy containing carboplatin (AUC >=4) for the first time.
4) Stage: Not specified (not specified with respect to postoperative adjuvant chemotherapy and advanced/recurrent cancer).
5) Combined use of molecular-targeting drugs: Not specified.
6) Patients from whom consent to participation in this study is obtained in writing.
Key exclusion criteria
1) Patients with serious hepatopathy or nephropathy.
2) Patients suffering from nausea or vomiting within 24 hours before the start of chemotherapy.
3) Patients receiving antiemetic drugs within 24 hours before the start of chemotherapy.
4) Patients with emetogenic factors other than chemotherapy (such as brain tumor, gastrointestinal obstruction, active peptic ulcer, and brain metastasis).
5) Patients who have received radiation therapy or are scheduled to receive it to the abdominal region or pelvis within 1 week before or after the start of the study.
6) Patients with concomitant diseases that make 3-day dexamethasone therapy impossible, such as uncontrolled diabetes mellitus.
7) Pregnant women, women who wish to become pregnant, and breast-feeding women.
8) Patients on treatment with pimozide.
9) Other patients whom the investigator considers to be unfit for enrollment in the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Okada |
Organization
Kyushu Medical Center
Division name
Clinical Research Institute
Zip code
Address
1-8-1, Jigyohama, Chuo-ku, Fukuoka-shi Fukuoka 810-8563 Japan
TEL
092-852-0700
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keita Uchino |
Organization
Kyushu Medical Center
Division name
Clinical Research Institute
Zip code
Address
1-8-1, Jigyohama, Chuo-ku, Fukuoka-shi Fukuoka 810-8563 Japan
TEL
092-852-0700
Homepage URL
keitauch@kyumed.jp
Sponsor or person
Institute
Kyushu Medical Center
Clinical Research Institute
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
九州医療センター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 07 | 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 | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 07 | Day |
Last modified on
| 2015 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011926
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