UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036489 |
|---|---|
| Receipt number | R000040472 |
| Scientific Title | A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for cisplatin containing regimen |
| Date of disclosure of the study information | 2019/04/15 |
| Last modified on | 2024/04/15 10:04:57 |
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Basic information
Public title
A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for cisplatin containing regimen
Acronym
PATROL-1
Scientific Title
A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for cisplatin containing regimen
Scientific Title:Acronym
PATROL-1
Region
| Japan |
Condition
Condition
malignant tumor(only solid tumor)
Classification by specialty
| Gastroenterology | Pneumology | Hematology and clinical oncology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the triplet antiemetic therapy with palonosetron, aprepitant, and olanzapine for preventing cisplatin-induced nausea and vomiting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total Control (no vomiting/retching, no rescue medication, and no nausea) proportion within 120 hours after the initiation of cisplatin administration
Key secondary outcomes
1. TC proportion during acute phase (0-24 h) and delayed phase (24-120 h)
2. Complete response (CR: no vomiting/retching, no rescue medication) proportion for the overall phase, the acute phase and the delayed phase
3. Complete control (CC: no vomiting/retching, no rescue medication, and no more than mild nausea) proportion for the overall phase, the acute phase and the delayed phase
4. The proportion of "no nausea" for the overall phase, the acute phase and the delayed phase
5. Time to treatment failure
6. Adverse events
7. Relationship between antiemetic efficacy and pharmacogenomic biomarkers (Exploratory analysis)
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
Palonosetron + Aprepitant + Olanzapine (5 mg)
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
Male and Female
Key inclusion criteria
1) Patients with malignant tumor except for hematopoietic malignancy
2) Patients who are over 20 years old at thetime of registration
3) Cisplatin-naive solid malignant tumor patients who will receive cisplatin (>=50 mg/m2)-based chemotherapy
4) Eastern Cooperative Oncology Group(ECOG) performance status(PS) of 0, 1 or 2
5) Patients who have adequate organ functions
<Each of the following values are examined within 2 weeks before registration for this study>
ALT < 100 U/L
AST < 100 U/L
T-Bil < 2.0 mg/dL
CCr >= 55 mL/min
6) Patients who got written informed consent prior to registration
Key exclusion criteria
1) Patients who has history of hypersensitivity or allergy for study drugs or similar compounds.
2) Patients taking systemic corticosteroid (oral and intravenous) except for
inhaled or topical corticosteroid preparation
3) Patients having a clear vomiting symptom such as brain metastasis or gastrointestinal obstruction to the passage of foods
4) Patients with symptomatic ascites or pleural effusions requiring therapeutic puncture
5) Patients with obstruction of gastrointestinal tract, for example gastric outlet or ileus etc.
6) Patients who have convulsive disorders requiring anticonvulsants therapy
7) Patients receieving adrenaline or pimozide
8) Patients who start taking opioids within 48 h prior to registration
9) Patients who received radiation therapy to abdomen or pelvis within 6 days prior to registration or will receive radiation therapy until 6 days after cisplatin administration
10) Patients regularly taking antiemetics other than study drugs
11) Patients who cannot be hospitalized after administration of cisplatin during 6 days
12) Pregnant, breastfeeding or expecting women or who do not wish to use contraception
13) Patients with diabetes mellitus receiving treatment of antidiabetic agents or having HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1 within 28 days before registration
14) Patients with smoking habit
15) Patients who are judged to be inappropriate for the study by the investigator
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | WATANABE |
Organization
Shizuoka General Hospital
Division name
Department of Gastroenterological Surgery
Zip code
420-8527
Address
4-27-1 Kita Ando Aoi-ku, Shizuoka City, 420-8527, Japan.
TEL
054-247-6111
masaya-watanabe@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | TSUJI |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences, Department of Clinical Pharmacology & Genetics
Zip code
422-8526
Address
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, JAPAN
TEL
054-264-5674
Homepage URL
d-tsuji@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka, School of Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka, School of Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Shizuoka
Address
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, JAPAN
Tel
054-264-5102
tyous10@u-shizuoka-ken.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Not published
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10637-023-01414-y
Number of participants that the trial has enrolled
85
Results
The percentage of patients who achieved TC during the overall phase, the primary endpoint of this study was 31.3%.
CR was achieved in 61.4%, 84.3%, and 65.1% of patients during the overall, acute, and delayed phases, respectively. The most frequently reported adverse event was anorexia. The primary endpoint was below the threshold and we could not find benefit in the dexamethasone-free regimen, but CR during the overall phase was similar to that of the conventional three-drug regimen.
Results date posted
| 2024 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Chemotherapy-naive patients scheduled to receive cisplatin.
Participant flow
Patients were evaluated for the occurrence of chemotherapy-induced nausea and vomiting during 120 hours after chemotherapy.
Adverse events
Adverse events were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
No patients discontinued treatment due to adverse events, and no unexpected serious adverse events attributable to the antiemetic regimen occurred during the observation period. The most common treatment-related adverse events were anorexia and constipation.
Outcome measures
The primary endpoint of the study was total control (TC) in the overall phase. The key secondary endpoint was complete response (CR), which was assessed in the acute, delayed, and overall phases, respectively. Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) ver. 5.0.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040472
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