UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005628
Receipt number R000006652
Scientific Title Pharmacogenomic study of TPF regimen (combination chemotherapy of docetaxel, cisplatin, and 5-fluorouracil) in hypopharyngeal cancer
Date of disclosure of the study information 2011/05/25
Last modified on 2019/05/30 15:55:05

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Basic information

Public title

Pharmacogenomic study of TPF regimen (combination chemotherapy of docetaxel, cisplatin, and 5-fluorouracil) in hypopharyngeal cancer

Acronym

Pharmacogenomic study of TPF regimen in hypopharyngeal cancer

Scientific Title

Pharmacogenomic study of TPF regimen (combination chemotherapy of docetaxel, cisplatin, and 5-fluorouracil) in hypopharyngeal cancer

Scientific Title:Acronym

Pharmacogenomic study of TPF regimen in hypopharyngeal cancer

Region

Japan


Condition

Condition

Hypopharyngeal cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To assess the efficacy and safety of combination chemotherapy for stage III, and IV locally advanced hypopharyngeal squamous cell carcinoma. Predictive factors for these outcomes will be assessed by pharmacogenomics analysis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Response rate (RECIST)

Key secondary outcomes

markers.


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

Iv, administration of TXT (75mg/m2) and CDDP(75mg/m2) on day1. Continuous iv infusion of 5-FU (750mg/m2/day) from day 1 to day 5. 1cycle. 28 days. Equal to or more than 2 cycle (max 4cycles).

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

Histologically confirmed squamous cell carcinoma of hypopharynx.
2) Stage III, and IV case.
3) The patient must have measurable disease (RECIST)
4) Any therapy should not have been given for the current disease.
5) Age 20 years or older
6) ECOG Performance Status 0-2
7) Patient must have appropriate organ function (bone marrow, liver, kidney, cardiac, etc.) and the laboratory value within 7 days before the protocol treatment must be
WBC 4,000/mm3 or more
ANC 2,000/mm3 or more
Platelet 100,000/mm3 or more
Hemoglobin 9.0g/dl or more
AST, ALT x2 institutional ULN or less
Serum Total Bilirubin 1.5 mg/dL or less
Serum Creatinine 1.5 mg/dL or less
Creatinine clearance 60 ml/min or more
BUN 25mg/dl or less
ECG Normal
8) Collected tissue sample with biopsy enough for genomic analysis.
9) Life expectancy must be 12 weeks or more.
10) Written informed consent must be obtained for the study including blood or tissue sampling.

Key exclusion criteria

Patients who did not meet the above mentioned inclusion criteria.
2) No distant metastases were existed when treatment was started.
3) Patients with severe hypersensitivities or drug allergy.
4) Patients with history of hypersensitivity reactions to polysorbate 80.
5) Patients with considerable cancerous body cavity fluid.
6) Patients with obvious infectious disease
7) Patients with watery diarrhea.
8) Patients with intestinal paralysis or obstruction.
9) Patients with severe aspiration, and high risk for aspiration pneumonia.
10) Patients with severe complications. (Examples: pulmonary fibrosis, interstitial pneumonia, tendency to bleed, active bleeding with necessity for frequent transfusion.)
11) Patients with peripheral (sensory or motor) neuropathy Grade 2 or greater.
12) Patients with edema Grade 2 or greater.
13) Patients with continuous administration of phenytoin, and warfarin potassium.
14) Patients with liver cirrhosis.
15) Patients with active double cancer.
16) Patients with uncontrollable diabetes
17) Patients with clinically serious cardiac disease.
18) Patients with clnically serious psycho-neurological disease for continuation therapy.
19) Patients who are pregnant or breast feeding or possibility of pregnancy
20) Patients whom investigators determined it impossible to complete the protocol treatment safely.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Masashi
Middle name
Last name Sugasawa

Organization

Saitama Medical University, International Medical Center

Division name

Department of Head and Neck Surgery

Zip code

350-1298

Address

1397-1 Yamane, Hidaka City, Saitama, Japan

TEL

042-984-4629

Email

msuga@saitama-med.ac.jp


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Sugasawa

Organization

Saitama Medical University, International Medical Center

Division name

Department of Head and Neck Surgery

Zip code

350-1298

Address

1397-1 Yamane, Hidaka City, Saitama, Japan.

TEL

042-984-4629

Homepage URL


Email

msuga@saitama-med.ac.jp


Sponsor or person

Institute

Department of Head and Neck Surgery, Saitama Medical University International Medical Center

Institute

Department

Personal name



Funding Source

Organization

Department of Head and Neck Surgery, International Medical Center, Saitama medical university.

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

Saitama Medical university IRB committee

Address

38 Morohongo Moyoyama Saitama Japan

Tel

049-276-2143

Email

rinri@saitama-med.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

埼玉医科大学国際医療センター(埼玉県)


Other administrative information

Date of disclosure of the study information

2011 Year 05 Month 25 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

14

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

Terminated

Date of protocol fixation

2011 Year 04 Month 25 Day

Date of IRB

2011 Year 04 Month 25 Day

Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 05 Month 23 Day

Last modified on

2019 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006652


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name