UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008333 |
|---|---|
| Receipt number | R000009482 |
| Scientific Title | Phase II Trial of Chemotherapy with Docetaxel plus Cisplatin for Patients with Recurrent or Metastatic Non-squamous Cell Carcinoma of Head and Neck |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2021/09/27 09:31:26 |
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Basic information
Public title
Phase II Trial of Chemotherapy with Docetaxel plus Cisplatin for Patients with Recurrent or Metastatic Non-squamous Cell Carcinoma of Head and Neck
Acronym
HN non-SCC_P2_DC
Scientific Title
Phase II Trial of Chemotherapy with Docetaxel plus Cisplatin for Patients with Recurrent or Metastatic Non-squamous Cell Carcinoma of Head and Neck
Scientific Title:Acronym
HN non-SCC_P2_DC
Region
| Japan |
Condition
Condition
Patients with recurrent or metastatic non-squamous cell carcinoma of head and neck
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of chemotherapy with Docetaxel plus Cisplatin for Patients with recurrent or metastatic non-squamous cell carcinoma of head and neck
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Disease control rate, Overall survival, Progression free survival, Adverse events
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
Docetaxel 75 mg/m2 + Cisplatin 75 mg/m2 q3weeks 6 cycles
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) Pathologically proven head and neck non squamous cell carcinoma (HN-nonSCC)
2) Unresectable recurrent or metastatic disease
3) Prior chemotherapies defined as the follows
a) NOT include platinums, or previous platinums completed at 24 weeks from progression
b) NOT include taxanes
4) Progressive disease defined as one of the following occurring within 6 months of study entry
a) At least a 20% increase in radiologically or clinically measurable disease
b) Appearance of new lesions
c) Deterioration in clinical status
5) One or more measurable lesions
6) Aged 20 years or older
7) ECOG perfomance status 0-1
8) Adequate bone marrow, hepatic, renal and cardiopulmonary function
9) Life expectancy of at least 12 weeks
10) Written informed consent
Key exclusion criteria
1) Interval of at least 4 weeks from last surgery or radiotherapy, or interval of at least 2 weeks from last chemotherapy
2) Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
3) Active infection
4) Active concomitant malignancy
5) Symptomatic CNS metastases
6) Patients with uncontrollable complications
7) Pregnant, breast-feeding, or unwilling to use adequate contraception
8) HBsAg-positive
9) Other conditions inadequate for this research
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Kiyota |
Organization
Kobe University Hospital and Graduate School of Medicine
Division name
Medical Oncology / Hematology, Department of Medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5820
nkiyota@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Imamura |
Organization
Kobe University Hospital and Graduate School of Medicine
Division name
Medical Oncology / Hematology, Department of Medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5820
Homepage URL
yimamura@med.kobe-u.ac.jp
Sponsor or person
Institute
Medical Oncology / Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Medical Oncology / Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
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
Kobe University Hospital, Clinical & Translational Resarch Center
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6669
kainyu@med.kobe-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
京都府立医科大学附属病院（京都府）、奈良県立医科大学附属病院（奈良県）、兵庫県立がんセンター（兵庫県）、大阪府立成人病センター（大阪府）、近畿大学医学部附属病院（大阪府）、国立病院機構東京医療センター（東京都）、宮城県立がんセンター（宮城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.med.kobe-u.ac.jp/oncolo/
Publication of results
Partially published
Result
URL related to results and publications
https://oncologypro.esmo.org/meeting-resources/esmo-2018-congress/A-Phase-II-Trial-of-Docetaxel-plus
Number of participants that the trial has enrolled
23
Results
DC regimen demonstrated promising efficacy in patients with R/M HN non-SCC.
- ORR 45.5%, DCR 95.5%
- mPFS 6.7 months, mOS 20.1 months
No treatment-related deaths were observed.
- FN 39%
Prophylactic antibiotics seems to be effective.
- 57 vs 11% (post-hoc analysis)
Results date posted
| 2020 | Year | 03 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
median age: 57 years-old
male: 8 (35%)
salivary gland: 12 (52%)
adenoid cystic carcinoma: 10 (43%)
Participant flow
registration after checking eligibility in every institution
Adverse events
G3/4>10%
neutropenia: 92%
anemia: 22%
febrile neutropenia: 39%
fatigue: 13%
appetite loss: 17%
Outcome measures
- ORR 45.5%, DCR 95.5%
- mPFS 6.7 months, mOS 20.1 months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
JSMO2018, O1-8-1
Imamura Y, Tanaka K, Naomi K, Hayashi H, Ota I, Arai A, Iwae S, Minami S, Yane K, Yamazaki T, Nagatani Y, Toyoda M, Otsuski N, Nibu K, Minami H. Docetaxel and cisplatin in recurrent and/or metastatic non-squamous cell carcinoma of the head and neck: a multicenter phase II trial. Medical Oncol 2021; 38: 128. doi: 1007/s12032-021-01581-z
Management information
Registered date
| 2012 | Year | 07 | Month | 03 | Day |
Last modified on
| 2021 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009482
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