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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008333
Receipt No. 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 2020/03/01

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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
Middle name
Last name Naomi Kiyota
Organization Kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology / Hematology, Department of Medicine
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5820
Email yimamura@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Imamura
Organization Kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology / Hematology, Department of Medicine
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5820
Homepage URL
Email yimamura@med.kobe-u.ac.jp

Sponsor
Institute Medical Oncology / Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
Institute
Department

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
Address
Tel
Email

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
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

Management information
Registered date
2012 Year 07 Month 03 Day
Last modified on
2020 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009482

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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