Unique ID issued by UMIN | UMIN000038644 |
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Receipt number | R000042017 |
Scientific Title | A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for highly emetogenic chemotherapy in breast cancer. |
Date of disclosure of the study information | 2019/11/20 |
Last modified on | 2022/01/06 10:12:12 |
A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for highly emetogenic chemotherapy in breast cancer.
PATROL-II
A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for highly emetogenic chemotherapy in breast cancer.
PATROL-II
Japan |
breast cancer
Hematology and clinical oncology | Not applicable |
Malignancy
YES
Efficacy of antiemetic therapy with a combination of palonosetron (PALO), aprepitant (APR), and olanzapine (OLN) without steroids for patients with malignancies scheduled to receive initial treatment with highly emetogenic chemotherapy for breast cancer and safety in the phase II trial.
Safety,Efficacy
Total Control in overall phase
1 TC ratio in acute and late phase
2 Complete response of all period and acute phase, late phase
3 Complete control of all periods and acute and late stages
4 No nausea for all period and acute phase, late phase
5 Time to treatment failure (TTF)
6 adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Palonosetron + Aprepitant + Olanzapine (5 mg)
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with breast cancer
2) Patients who are over 20 years old at thetime of registration
3) The patients whom highly emetogenic chemotherapy for breast cancer is given in for the first time
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
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) Pregnant, breastfeeding or expecting women or who do not wish to use contraception
12) Patients with diabetes mellitus receiving treatment of antidiabetic agents or having HbA1c (NGSP) 6.5 or more,
or HbA1c (NGSP) in less than 28 days before registration is the patient with (in the case of JDS more than 6.1%) 6.5% or more.
13) Patients with smoking habit
14) The patients who have difficulty in operation such as the input, and the like of EDC.
15) Patients who are judged to be inappropriate for the study by the investigator
89
1st name | Toshihiro |
Middle name | |
Last name | Hama |
Japanese Foundation for Cancer Reseach
Cancer Institute Hospital
Department of Pharmacy
135-8550
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
03-3520-0111
toshihiro.hama@jfcr.or.jp
1st name | Kenichi |
Middle name | |
Last name | Suzuki |
Hoshi University
Division of Applied Pharmaceutical
142-8501
Ebara 2-4-41, Shinagawa-ku, Tokyo 142-8501, Japan
03-5498-6241
kenichi-suzuki@hoshi.ac.jp
Hoshi University
Division of Applied Pharmaceutical
University of Shizuoka, School of Pharmaceutical Sciences
Other
Japanese Foundation for Cancer Reseach Cancer Institute Hospital
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
03-3520-0111
med.shinsa@jfcr.or.jp
NO
2019 | Year | 11 | Month | 20 | Day |
Unpublished
Open public recruiting
2019 | Year | 05 | Month | 01 | Day |
2019 | Year | 10 | Month | 16 | Day |
2019 | Year | 12 | Month | 10 | Day |
2022 | Year | 06 | Month | 30 | Day |
2019 | Year | 11 | Month | 20 | Day |
2022 | Year | 01 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042017
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